Director qa - united states, new bedford

director quality assurance

degree:
- bs degree in chemistry, biology, microbiology or equivalent.

experience:
- minimum 12 yrs. exp. in the pharmaceutical/biotech industry with a minimum of 7 years’ experience in a quality leadership position.

"must haves":
- exp. overseeing the qa within internal manufacturing operations.
- comprehensive knowledge of gmp regulations and guidelines.
- exp. in several disciplines of quality which may include: operations, compliance, quality systems, quality control, quality assurance validation.

"nice to haves":
- exp. with audits, final fill, packaging, and labeling is a plus

duties/responsibilities:
- manage and develop qa operations team that provides oversight of quality management system elements, including but not limited to deviations, corrective and preventive actions (capa), change control, and disposition in support of gmp manufacturing operations.
- lead qa oversight of manufacturing operations in a dynamic gene therapy manufacturing facility. employ a phase appropriate, risked based approach to optimize efficiency and maintain compliance/safety.
- provide strategic oversight of manufacturing floor operations and drive timely batch record reviews and product disposition to enable clinical trials.
- provide quality expertise and mentoring on drafting/approval of risk assessments and investigations.
- develop, implement, and maintain sops for oversight of the manufacturing, testing, and release of raw materials, intermediates, drug substance and drug product.
- manage qav activities to support the ongoing implementation of new gxp equipment and computerized systems.
- support preparation for inspections and partner audits. develop and execute internal audit plans.

location: bedford, ma. area
start date: asap!
duration: direct hire

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