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  1. 1. Provide a clear description of your needs and your expectations of an expert, consultant or job candidate and Zintro will match it with the most relevant professionals in our platform.
  2. 2. Within a day or two typically 6 - 12 Experts, who have opted-in, will contact you with a brief explanation of their qualifications and how they can help.
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Recent Quality Systems Inquiries

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Commercial Quality Assurance In California

This is a full time opportunity in california: sr. Director, quality assurance - commercial overview: this position will have oversight and leadership of the commercial quality and quality systems teams and be responsible to meet compliance and quality assurance requirements for commercial pharmaceutical manufacturing. Responsibilities: -effectively employ the principles of ich q9 (risk management) and ich q10 (pharmaceutical quality system) -develop and lead a risk based quality management system. -build and maintain robust quality program that will effectively support commercial manufacturing. -provide leadership and managerial oversight to the quality departments responsible for quality systems and commercial quality. -administer commercial quality systems including: -deviation -capa -change control -vendor management -training -internal/external audits -document control -quality management review -annual product review -product/customer complaints quality oversight of contract manufacturing organizations including: -auditing -deviation/change control -batch record review -batch release provide support as necessary to the vp global quality regarding gmp readiness, quality related projects and issues/concerns on a global basis. -conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved. -interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate dynavax processes and procedures. -conduct regular risk assessments to ensure processes and procedures are in compliance with cgmps. -supervise and develop quality personnel including the heads of applicable functional teams. Appropriately resource regulatory inspections. -direct the review and approval of the quality manual, quality policies, protocols, sops, batch records, test methods, raw material specifications, and annual product reviews. -provide quality expertise as needed for deviations reports and out-of-specification reports. -ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust change control system and procedures are developed and maintained to meet state, federal, and international requirements. -ensure that suppliers and contract manufacturers are operating in compliance with state, federal, and international gxp regulations and guidelines through an external audit program. -hire and/or develop the team to establish and maintain efficient and effective quality systems and programs. -develop operational budgets, cost controls, cost estimates, capacity and resource plans as well as facility requirements to support corporate strategic business objectives.. qualifications: -ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, must have at least 2 years’ experience at the director level. -must have a quality background from the biotechnology/pharmaceutical industry with gmp experience and a successful track record in quality within fda and/or emea regulated environment. -experience in quality management and compliance systems. -in-depth knowledge of qa document control, gxp compliance, and qa auditing. -experience in development qa associated with pre-clinical development and commercial products. --a background in the development of analytical methods preferred. -must have a successful track record in managing fda/eu inspections. Contact us here on zintro for further details.

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    Stefan |Senior Researcher

    I am more than interested of your job offer and despite the fact of being of the age of more than 60...

    5.9 Hours Later
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    Arun Kumar |Associate

    I am keen to explore the said opportunity. Please provide your e-mail address so that I can provide ...

    6.9 Hours Later
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    EMMANUEL |Managing Partner - Independent Contracto

    Kunda Emmanuel Kalaba Address: 1 Tanamerah Kechil Road Singapore – Postal Code ***** Email: kunda....

    5.6 Days Later
+11 Other Responses
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Fda Quality System

We need a fda consultant to assist us to meet fda quality system requirements.

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    Joginder |Project Manager Pharma GMP Compliance: V

    Hello , Greetings!! I have been in the Pharma industry for more than 10 years and have worked on d...

    1.1 Hours Later
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    Avner |Quality & Regulation Advisure

    Hello. I will be happy to help you, Regards...

    1.4 Hours Later
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    Robert |Management Consultant

    My ***** I work with medical device ventures, providing product development, manufacturing d...

    4.6 Hours Later
+34 Other Responses
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Gcp Quality Systems Consultants/

Tei biosciences is an established medical devices company selling a cellular dermal matrix tissue replacement products for burns, wounds and surgery. We are establishing an in-house gcp quality program for fda/iso-regulated clinical trials. We desire review of our draft system (sops/edc) for compliance.

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    Les |Principal

    I would be happy to help you with this issue and provide the initial consult at No Charge. Please c...

    1.3 Hours Later
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    Brett |Principal Consultant, ComplianceLogix LL

    Dear Bret-Jessee, Thank you for your inquiry on Zintro. I would be happy to discuss the project fo...

    1.7 Hours Later
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    Jack |CEO/President

    We have a significant amount of work in setting and auditing Quality Systems. We are extremely fami...

    6.4 Hours Later
+8 Other Responses
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Food Safety

Senior vice president of quality assurance, food safety and regulatory-nutrition food ingredients our client is a highly recognized and highly successful company in the development and sales of proprietary and patented food and nutrition ingredients. Their food & beverage ingredient products (those sold now and those under development) include unique, value added nutritional food ingredients that have properties that lead to improved health when added as part of a mainstream food & beverage product. The company has received many numerous awards and recognition that validate the value of their products and technologies. Their industry partners and customers include many of the world’s top food & beverage companies. The senior vice president of quality assurance, food safety and regulatory is the company’s top executive responsible for all global quality, food safety and regulatory initiatives. This includes the development and leadership of all quality assurance strategies and processes, including quality management systems. The position leads an existing quality and regulatory organization that has 5 director/vp level direct reports, and 19 indirect management level indirect reports. Responsibilities include developing and maintaining a corporate quality system including quality policies, processes and sop’s, educate workforce in their appropriate application, and monitor ongoing compliance. Design, establish and maintain an organizational structure, staffing, and the physical infrastructure needed to effectively grow the organization and accomplish the organization's goals and objectives. Review and approve annual budgets for operating expenses and capital investment.

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    Rania |Owner, Essential Nutrition For You

    Hello, As a Food Brand Consultant I can work with your team to develop messages reltaed to educating...

    1.2 Hours Later
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    Lisa |President, Chief Consultant

    Where is the workplace located?...

    1.4 Hours Later
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    Ward |Consultant

    Dear dvale, I received your request although I throught I secified my expertise in animal (aquacultu...

    1.4 Hours Later
+20 Other Responses
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Quality Systems

We are seeking a quality systems specialist for a full-time position based in cambridge, ma. ***to be considered for this job, candidates must reply with a brief summary of their relevant experience and attach their latest resume as a word doc or pdf file over here. ***job summary: under the direction of the quality affairs manager, the quality system specialist is responsible for the development and management of robust and integrated quality management systems. The quality systems specialist must coordinate the use of processes and systems to complete tasks as well as guide and encourage personnel to successful completion of projects and tasks. The quality systems specialist must coordinate daily assignments as well as project-based work with minimal day to day supervision. ***job responsibilities include and not limited to: - responsible for the management and daily oversight of the document control, training management, and records management/archival programs in support of all laboratory testing and studies including nonclinical, clinical, and diagnostic patient testing conducted under glp, gclp. Cap, clia, and nys doh clep regulations and standards. - provide insight and consultation for the development and management of all quality, laboratory, and company processes and systems (e.G., capas, deviations, equipment management, data management, auditing, continuous improvement, quality control, change control, computer system validation, etc.). - act as a technical writer, editor, and reviewer of all relevant or assigned content (e.G., sops, forms, templates, protocols, reports, policies, training material, etc.). - act as the designated glp archivist for the company and oversee the storage, organization, and retrieval of company documentation and records. - act as a business analyst, subject matter expert, and administrator for electronic quality and process systems. - participate in/lead computer system validation of assigned systems. - represent assigned quality systems during client and regulatory audits and inspections and ensure processes are in place for the documentation of our company's compliance with relevant regulations. - enforce compliance with all relevant regulations, standards, guidelines, and company procedures. - provides project leadership and management for quality systems-related projects. ***please reply and attach your latest resume at a word doc or pdf file over here. ***competitive salary and benefits. Note: this full-time job position does not provide visa sponsorship and no relocation available.

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    John |Principle & Senior Consultant

    I am interested in this position....

    3 Days Later
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    Sabrina |

    Dear Recruiter I’m so excited to respond to the Quality Systems Specialist role and it seems lik...

    25.2 Days Later
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    New |

    Brendan P. Mehu 11 Snow Street #1L, Brighton, MA ***** Phone: (781) ***** E-mail: *****.c...

    25.7 Days Later
+44 Other Responses
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Quality Assurance Development In California

This is a sr. Director of quality assurance,development full time position opportunity in california. Overview: this position will have oversight and leadership of developmental quality assurance programs to meet phase appropriate compliance, validation, and gxp quality assurance requirements. Responsibilities: -establish and maintain a robust quality program that will effectively support the various phases of drug development – preclinical through phase 3, plus product/process improvements. -employ the principles of ich q8 (pharmaceutical development) and q9 (risk management) to the development of manufacturing processes. -ensure a systematic approach to development is employed that begins with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management. -provide leadership and managerial oversight to the quality department responsible for development qa. -establish and maintain a phase appropriate approach to product/process development qa. -as project team member, represent qa on product development teams including pre-clinical, phase 1, 2, and 3 development studies, and manufacturing improvement teams. -responsible for document review and qa release of ds/dp to be used in phase 1, 2, and 3 clinical studies. -responsible for phase appropriate quality systems implementation for ds/dp manufactured for use in phase 1, 2, and 3 clinical studies. -acts as technical advisor to vp global quality on topics related to development and commercial quality. -develop and implement effective development qa programs aligned with corporate strategic initiatives and business goals. -interpret regulatory authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate processes and procedures as they pertain to product development activities. -must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines. -supervise and develop quality personnel. -direct the review and approval of the applicable sops, batch records, test methods, raw material specifications. -provide quality expertise as needed for deviations reports and out-of-specification reports. -ensure that manufacturing processes, equipment, facilities meet phase appropriate gmp requirements. -ensure that suppliers and contract manufacturers associated with product/process development are operating in compliance with state, federal, and international gxp regulations and guidelines as necessary through an external audit program. -hire and/or develop the team to establish and maintain efficient and effective quality systems and programs as they relate to product/process development. -develop operational budgets, cost controls, cost estimates, capacity and resource plans to support corporate strategic business objectives. Qualifications: -ba/bs in a relevant scientific discipline and a minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance. For senior director level consideration, the ideal candidate must have at least 2 years’ experience at the director level. -must have a development quality background from the biotechnology/pharmaceutical industry. -experience in quality management and compliance systems. -in-depth knowledge development qa and experience implementing phase appropriate quality systems to achieve gxp compliance. Contact us here on zintro for further details.

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    Frederick |President

    Thank you for the opportunity- but this is way outside my area of expertise. Best wishes and good l...

    13.4 Hours Later
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    Monica |QA Specialist

    I`m interested in the proposal, please let me know where I can send you my resume. I have to say tha...

    21.9 Hours Later
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    Michael |CMSO , Chief Medical Strategies Officer

    Thanks...but i live in NY.....great opportunity!...

    1.7 Days Later
+13 Other Responses
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Fda Cmc Regulatory

I am looking for a consultant with expertise regarding the qa process for fda cmc regulatory approval. Ideally, the consultant would be familiar with oral agents and elixirs.

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    Tai Wei |Sr. Director of Drug Development Technol

    I believe I should be able to help you with your query. I have been responsible for CMC in all our ...

    1 Hour Later
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    Plamena |President & Principal Consultant

    Hello - our consultancy can definitely assist you with your project; I have 10 years of RA with a fo...

    1 Hour Later
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    Nicholas |Director R&D

    I am a *****rance consultant and worked in the pharma area for over 30 years. The last te...

    1.1 Hours Later
+24 Other Responses
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News Blog Writing

I am looking for blog and news piece writers, who can write about medical device, food and cosmetics industry trends, innovations and their regulatory requirements. This is a long term project, and will involve creating content on a regular basis. We can pay $8 per 400 to 500 words article. Please let us know if you'd be interested. Please share two samples of your previous work. Thanks!

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    New |

    I want to offer my content writing skills for this job. Kindly visit this website for my blogs. blog...

    4.1 Hours Later
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    Judy Seybold |Zintro Expert

    Consumer, healthcare professional and technical writing offered. ...

    5.9 Hours Later
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    New |

    I have experience of writing global *****irement for medical devices and IVDs products. ...

    9.5 Hours Later
+14 Other Responses
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Product Inspection

We would like to speak with vps/ directors/ regional heads/ country heads for sales and/or marketing, product heads, and other similar roles in north america and europe who can discuss handling of vision detection, x-ray detection, metal detection, checkweighers. We are interested in learning about the revenue, unit shipments, and the market landscape of these products. This is a paid 1-hour online interview for $200. Please provide a brief answer as to your relevance to the space below: 1. Do you handle vision detection, x-ray detection, metal detection, checkweighers? 2. Can you discuss the revenue, unit shipments, and the market landscape of these products? **please note that we are only interested in your personal point of view and are not seeking confidential information. ***referrals are highly appreciated.

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    Engin |Zintro Expert

    More than 10 years of global experience in vision detection systems....

    1.5 Hours Later
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    Alton |Director, Food Safety

    I have extensive experience with metal detectors, x-ray systems, checkweighers and vision systems li...

    3.7 Hours Later
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    Yousef |Senior Consulting Engineer

    Please make an arrangement. Here is my contact numbers: Direct Phone.: ***** *****...

    15.3 Hours Later
+11 Other Responses
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Aerospace Quality Systems

Quality requirements for production of sikorsky landing gears

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    Carlos |Partner, Director

    sorry, no bid this time.....thank you...

    14.3 Hours Later
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    charles |manufacturing master planner

    I will accept your ***** this matter....

    1.1 Days Later
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    CHRISTINE |President

    My specialty is Pharmaceutical and Medical Device Quality Assurance so I do not believe I have the A...

    42 Days Later
+12 Other Responses
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Semiconductor Quality

Need expert consultant experienced in implementing and auditing iso/ts quality systems to evaluate and fill gaps in our china operation’s already approved iso/ts quality system before an upcoming key customer audit. Expert needs to have an emphasis in implementing/auditing continuous process improvement strategies. Prior experience working with a high volume semiconductor component manufacturer is a big plus.

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    Ray |Managing Engineer

    Dear JRC, My name is Ray Huang and I'm an Electrical Engineering consultant at Exponent here in Men...

    29 Minutes Later
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    Jason |Business Director

    Hi, I worked in semiconductor indutry and in quality management. contact me if you have additional n...

    1.8 Hours Later
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    HK |CSO

    Does JRC's manufacturing facility or supplier have formal QRA dept. to ***** quality problem ? ...

    4.6 Hours Later
+13 Other Responses
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Dinner Speaker For Quality Management

I'm the program dir for northern nv proj management institute. I'm looking for a dinner speaker on project quality control (maybe something like top 10 principles of qual mgt). The location is reno, nv. Best date is oct 23.

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    Thomas |CEO & Chairman

    FYI - I am sending this message on-the-fly with voice to text software on my iPhone. Please forgive ...

    1.5 Hours Later
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    David |Founder/Owner

    Hi qual5C7bQ7, Thank you for the kind offer bt I am gong to pass. Best regards, Dave Pittinger...

    2 Hours Later
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    Mohammed |Director

    I would recommend Dr. Iltifat Hasan, Senior Director at Teva. I am forwarding this inquiry to him...

    2.1 Hours Later
+9 Other Responses
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