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
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