Quality Assurance Manager

Oversees the development, implementation and maintenance of quality assurance systems and activities. Oversees generation and review of documents used in good manufacturing practices.  May lead investigations, resolve potential product quality issues, or make recommendations for improvement.  Selects, develops and evaluates personnel to ensure the efficient operation of the function.

•Oversight and Support of GMP Quality Assurance Activities:
oProvides direct QA oversight of the GMP batch record review, data review, and batch disposition processes
oManages QA specialists to facilitate the batch review, data review, and batch release processes
oMaintains relationship and workflow with secondary packaging and labeling CMO to ensure timely batch record review and release
oDispositions products and approves COAs
oParticipates in investigations of deviations and product complaints
oEvaluates the impact of deviations and product complaints on product quality
oReviews and approves batch records, test methods, protocols and work instructions as required
oEnsures compliance to internal SOPs and regulatory requirements
oSupports regulatory inspections as subject matter expert for batch record review, data review, and batch disposition
oMonitors internal audits and supplier audits and provide audit support as necessary
oMonitors performance of quality systems and compiles documentation for management reviews and annual product reviews
oAssists in preparing and reviewing documents for regulatory submissions as needed
oProvides QA review and approval of validations and change controls as needed
•Innovation and Continuous Improvement:
oContinually evaluates quality systems supporting GMP manufacturing operations for potential improvements.
oGenerates and presents GMP training to the GMP operations team on relevant topics
oGenerates and implements policies and procedures in support of the clinical and commercial manufacturing facility
oGenerates and evaluates trend reports and metrics to measure key quality attributes in manufacturing operations
oGenerates corrective and preventive actions from internal and regulatory inspectional observations
oEnsures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events
•Other duties may be assigned as necessary

•Bachelor’s degree in a Life Sciences discipline or equivalent
•Minimum five (5) years of relevant experience in a regulated biotech or pharmaceutical industry
•Minimum of two (2) years in a quality supervisory position performing Quality Assurance functions including batch disposition
•Working knowledge of cGMPs, FDA regulations, and familiarity with the European Community guidelines for GMP
•Working knowledge of drug development and strong knowledge of operations in an aseptic processing facility
•Strong technical and scientific written and verbal communication skills are required
•Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member
•Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment
•Must be familiar with Microsoft Office applications