Job: QA Manager

Title QA Manager

Reporting to the Senior Vice-President Quality, the QA manager oversees Quality related activities at CMOs to assure compliance with applicable US FDA regulations. Is responsible for Quality Assurance Operations Support, Quality Release functions including batch record review and approval, review and approval of deviations and investigations and US Operations Quality Record Processing.

Specific Responsibilities
  • Reviews and approves all CMO generated batch records including both commercial and development batches
  • Reviews and approves GMP Investigations, Deviations and associated corrective/preventative action plan and specifications generated by the CMOs related to Amerigen contract manufactured or packaged product.
  • Oversees collection of Quality Metrics and APR data from various CMOs and assists in collating APR for FDA submission
  • Coordinates with the outsourced Complaint handling/ ADR Contractor to assure that complaints and ADR are appropriate handling and reports are completed in a timely fashion.
  • Reviews audits reports of CMO and ensures that CMOs audit responses are complete. Monitors CMOs CAPA plant to address audit observations
  • Systematically and consistently reviews QA activities to improve efficiencies and enhance compliance. Considers and proposes improvements whenever possible.
  • Other tasks assigned by Superior
Desired Skills & Experience
  • A minimum of 7+ years of experience in Pharmaceutical QA including, but not limited to Manufacturing CMO Management and GMP Service Provider management
  • BS in Science, life sciences or a related discipline
  • Understanding of and ability to communicate US FDA cGMP requirements
  • Detailed Documentation and Organization Skills
  • Problem solving and decision making skills
  • Strong Communication skills
  • Microsoft office, (i.e. email, Word)

Behavioral Characteristics

Trustworthy, Very Organized, Motivated/Engaged, Responsible, Professional team leader. Able to take direction from Quality Management. Can communicate well with subordinate, peers, superiors including upper management of corporation and staffs of CMOs. Positive Attitude towards work, A Genuine Desire to maintain a GMP/cGMP compliant atmosphere. Learn and Grow in job function responsibility. Must be able to prioritize and execute work.

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