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.
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 LaterArun Kumar |Associate
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6.9 Hours LaterEMMANUEL |Managing Partner - Independent Contracto
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