Gxp & Research Applications In California
This is a new opportunity for a director, gxp & research applications full-time position in california.
reporting to the vp of information technology, this position will be responsible for defining and maintaining global gxp and r&d application services. The successful candidate will have extensive experience with pharmaceutical and biotech it systems, vendor management, cross-functional team management, cfr part 11 and gamp 5 regulations, systems validation, and change control.
This position will provide leadership to the application services team and the company. It will consult with the business to achieve successful gxp and r&d system development and completion of the it department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to application services staff while establishing and maintaining positive relationships with relevant business partners.
-provide production and development support for existing and future multi-tier gxp and research applications.
-execute agreed upon service levels (i.E. Project schedules, system availability, & service quality).
-review systems requirements and prepare recommendations anticipating future application needs.
-direct the analysis, design, development and installation of it supported applications in accordance with established sops.
-direct the it process development team to establish and maintain it sops, wis and related documents.
-partner with qa to manage systems validation, periodic reviews and vendor assessments.
-prepare operational forecasts and requirements, including monthly reports and budget analyses.
-provide regular performance feedback to employees including written performance reviews.
Lead individual projects as assigned using software development life cycle (sdlc) methodologies.
-bs degree in computer science, business or equivalent experience.
-ten to fifteen years of experience supporting gxp it systems with 3 to 5 years’ experience in the following:
-it biotech project management experience in a multinational environment;
-it management experience in a biotech/pharmaceutical environment managing systems supporting drug safety, pharmacovigilance, regulatory compliance, quality management and compliance, medical information or clinical trials software; and,
-it working knowledge in a biotech research and lab environment, familiar with lab systems implementation and system requirements.
-working knowledge of cfr part 11 requirements and direct experience with systems implementation in a validated environment.
-must possess an understanding of business processes related to pharmaceutical corporate activities.
Contact us here on zintro for more details.+6 Other Responses
Bio Research Quality & Compliance (brqc)
Bio research quality & compliance (brqc) - pharmaceutical r&d services
need expert with quantitative knowledge on supply market, market, pricing model, engagement model for quality assurance, quality analytics, quality management, quality management system oversight and quality planning & strategy of pharma r&d environment.
1. Supply capability analysis - supplier’s functional capability/ competency, client base information
2. Sourcing best practices - outsourced vs. In-house trend, cost drivers/components, costing/pricing models, resourcing/ engagement models, quality kpis for supplier selection
3. Market trends - macro level knowledge on how suppliers tackle local regulations and its impact on brqc, macro level trends on technology, innovation - modeling, predictive analytics and its impact on risk management, technologies that can support training, audits etc.Quality vs. Cost perspective - low cost sourcing.
Get in touch if you can help with all of above.+16 Other Responses
Quality Assurance Development In California
This is a sr. Director of quality assurance,development full time position opportunity in california.
this position will have oversight and leadership of developmental quality assurance programs to meet phase appropriate compliance, validation, and gxp quality assurance requirements.
-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.
-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.+13 Other Responses
Commercial Quality Assurance In California
This is a full time opportunity in california: sr. Director, quality assurance - commercial
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.
-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:
-quality management review
-annual product review
quality oversight of contract manufacturing organizations including:
-batch record review
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..
-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.+11 Other Responses
Looking for global qppv psur and pv/drug safety consultant for an ongoing project in basel, switzerland. This is a backfill for someone who is leaving in december so immediate availability is necessary. Message me for more details? Thx!+27 Other Responses
New Jersey Pharmaceutical Compliance
Compliance specialist - bergen county nj
essential job function: responsible for interacting with customers on quality issues. Responsible for the receipt of all notices of investigations and logging them into the investigations spreadsheet. Responsible for the receipt of independent capas and logging them into the capa spreadsheet. Responsible for reviewing investigation reports for accuracy, compliance and completion. Responsible for performing internal and external audits and completing the pertinent audit agenda and reports.
• pharmaceutical background
• excellent documentation
• bachelor's degree, in science field desired
• 3-5 years investigation experience
• 5+ years in qa role in pharma industry
• at least 2 years of auditing experience
• 3-5 years working in a department responsible for assigning and assessing the effectiveness of capa’s
• solid oral dosage experience, would also consider a candidate with experience in liquids, semi-solid, capsules, injectables (if candidate possesses all other qualifications!)
general information: experience in the pharmaceutical industry. Bachelor’s degree in science field desired.
Job responsibilities include but not limited to:
• investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident.
• perform root cause analysis.
• perform product impact assessment of deviations.
• provide qa support during the investigation process.
• perform tracking and trending of deviations and capas.
• prepare deviation and capa metrics on a monthly basis.
• provide support during fda inspections.
• responsible for the receipt all notices of investigations and logging them into the investigations spreadsheet.+4 Other Responses
Pharmaceutical Quality Assurance & Compliance
Silver ray, comprising a group of professionals with a combined experience of more than 150 years, is dedicated to empowering the pharma-biotech industry through knowledge dissemination thereby assuring quality. We are looking for smes in quality ops (q8, q9, q10, q11), compliance, gmp, ra) to join our advisory board. Persons based out of usa, europe, australia will be preferred. They should be proficient in training and/or consultancy. The engagement will be on an assignment basis with suitable compensation+57 Other Responses
Pharma R&d Strategy Project Opportunity
i'm a management consultant with **** in india, a strategy consulting firm founded at stanford university. One of our core areas of expertise is pharmaceuticals and we have advised more than 80% of the top 20 global majors, and leading indian players on a host of strategic issues.
We're currently in discussions with a mnc which is interested in scaling up their small r&d centre in india to develop products for emerging markets, which are currently being made in other locations in europe/ us. This would involve an assessment of the company's current development, manufacturing, regulatory, qc capabilities in india, assess what capabilities are needed to make the targeted products for the targeted markets, identify the gap, and where feasible help them scale-up the india centre to meet the requirements. In this context, i wanted to reach out to you to discuss if we could possibly work together.
If this opportunity interests you, please reach me at the number below, or at this mail id at the earliest.
sidharth+16 Other Responses
Pharmacovigilance Business Development
Job title: business development manager
job location: open (us and uk)
job type: full-time
please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please.
will work collaboratively with other colleagues to increase sales within the life sciences industry. Responsibilities will include full cycle sales including; researching, identifying, cold/warm calling, getting client meetings, listening and understanding client needs, addressing client concerns/objections, proposing solutions, negotiating, obtaining sows and closing the deal. Are expected to quickly develop credibility with customers/prospects and build trust through professionalism and knowledge of our services and products.
**essential duties and responsibilities**:
- prospect accounts focusing on safety related to our products and services
- identify and develop new accounts and following up on existing leads
- develop and maintain positive and productive relationships with key target accounts
- manage assigned accounts to generate both incremental and repeatable annual business
- initiate and manage rfi and rfp process and negotiate terms for all account programs and projects
- work collaboratively with the services organization to ensure a complete and professional delivery of our software and service solutions
- collaborate with our executives and smes to maximize account coverage
- maintain knowledgeable understanding of changing regulatory guidelines and mandates affecting the industry community
**job experience and qualifications**:
- must demonstrate a sustained (7+ years) and successful track record selling professional services to pharmaceutical, biotech, medical device, and/or clinical research organizations.
- selling drug safety consulting services and products is desired.
- candidates should exhibit an understanding of the regulatory pharmacovigilance process for both pre-marketed and post-marketed stages of a product.
- experience working with regulatory affairs departments, product safety related departments, or regulatory submissions is highly desired.
- experience with data-mining or statistical signal detection products is desirable.
- demonstrated track record of success working with senior level management in a fast paced growth environment is essential.
- full sales cycle experience is required (prospect, identify opportunities, propose solutions, negotiate, close).
- strong, quality-oriented proposal writing and proposal management experience.
- ambitious, driven and self-motivated personality is required.
- college degree or equivalent experience required.
- willing to travel throughout the us, estimated up to 80%.
- background in software as a service (saas) market is preferred.
- competitive base salary + commission.
- benefits: 100% medical/dental for employee and his/her family.
Interested applicants should reply with a brief summary of their relevant experience and attach their latest cv on zintro.
Please note: this position is only open to u.S. And u.K residents seeking full-time employment. No consultants please.+49 Other Responses
I am looking for pv auditor located in egypt and lebanon for pv audit that will happen in q4 2016.+11 Other Responses
Pharmaceutical Quality Control
We are a global research firm and an authorized zintro partner.
We are looking for experts who have good experience in the pharmaceutical space in quality control domain.
Expert with knowledge in designing / setting up a qc laboratory and managing a usfda approved qc laboratory would be relevant.
Some of the key aspects which are to be discussed are:
• best practices processes for managing inventory and managing flow and storage of samples
• ideas & techniques to improve analyst productivity inside the lab
this project is time critical and we would like to complete the consultation at the earliest.
Kindly respond with a brief description of your background in this area and share your contact details to set up the initial call. Thank you+10 Other Responses
i would like to ask you, if you are interested to be a local pv person in france.
We wish to submit a dcp in march 2015 for ibuprofen and paracetamol combination tablet . In accordance to article 104(4) of directive 2001/83/ec we require a contact person for pharmacovigilance issues at a national level for.
This local pharmacovigilance contact will report to the qualified person responsible for pharmacovigilance activities.
Can you please provide me with the price estimation for the above-mentioned activities?
Thank you in advance.
maciej+10 Other Responses