Quality Assurance Manager

Location: Lee, MA
Position Overview:
The successful candidate will be responsible for maintaining quality assurance systems including CAPA’s, deviations, Change Control. The position will have some responsibility for batch record review and approval and review and approval of engineering reports and documents
The ideal candidate will have a strong background in Quality Systems, have worked for at least 6 years in a pharmaceutical environment with increasing responsibilities in Quality System management. Experience in sterile manufacturing and a technical background are a plus.

Duties & Responsibilities:
  • Establish and maintain GMP’s in a sterile manufacturing company.
  • Working with engineering, manufacturing and quality control to close out excursions, deviations, CAPA’s and change control in a timely manner.
  • Review and approve executed documents including batch records, engineering reports, validation reports to meet client deadlines
  • Help draft, review and approve master batch records, protocols, material specifications, risk assessments and other documents.
  • Represent Quality during client audits, perform internal and external audits.
  • Provide daily support to the manufacturing group to ensure compliance with cGMPs and regulatory requirements.
  • Apply Quality by Design (“QbD”) principles for process design in collaboration with Manufacturing Operations team.
  • Provide both direction and supervision to junior staff, set goals and objectives

  • Authorized to work in the U.S.
  • 6+ years of relevant cGMP QA experience in the pharmaceutical industry in cGMP environment.
  • Minimum of bachelor degree, science or engineering degree preferred.
  • Familiarity with international regulations (FDA, EMEA) and standards (USP-, EP- and ICH-) in all phases of clinical development.
  • Ability to evaluate scientific/technical information from a Quality perspective.
  • Working knowledge of Quality Systems especially as it relates to deviations, change control, CAPAs, OOS, and risk management.
  • Demonstrated experience managing Quality Systems for drug product manufacturing for a pharmaceutical company and deep knowledge of cGMP.
  • Strong leadership skills, a developed team spirit and an ability to work with flexibility in a fast-paced, changing and demanding environment.

  • Based on experience

  • Competitive benefits package (Health/dental/vision/LTD)
April A. Estes
Senior Recruiter
720-439-2609 Direct

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