Manager, QA Compliance - GMP/GCP

San Diego, CA, United States
Apr 12, 2019
Required Education
Bachelors Degree
Position Type
Full time
This position oversees Quality Compliance and vendor qualification systems and compliance with regulatory requirements to include audits and documentation review. The Manager, Quality Compliance has had previous experience managing vendor qualification and auditing functions.

The Manager, QA Compliance is responsible for establishing and maintaining a robust vendor qualification plan, performing audits and managing 3 rd party resources as needed.

This position works with Quality Assurance, QC, Process Development, Manufacturing, Clinical Operations, Regulatory Affairs, as well as external laboratory and project management staff to achieve agreed-upon timeline projections and goals.

Duties and Responsibilities Include But Are Not Limited To:

  1. Collaborates with all functions to identify and document intended vendors and integrating them into the qualification plan. Close coordination across functions especially finance is essential.
  2. Independently performs or works with contractors to schedule and conduct audits and proactively support vendors to address findings.
  3. Interacts with CMOs and CROs, initiates and follows up on inquiries.
  4. Revises and approves SOPs as needed based on continuous improvement of CAPA implementation.
  5. Ensures completeness and accuracy of information contained in reports, document files, databases, and documentation systems requiring QA review or approval.
  6. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  7. Communicates scientific concepts, approaches and final results to others inside and outside the organization.
  8. May assist with other Quality Systems responsibilities as needed based on additional areas of expertise, such as raw materials, and assay development, qualification, and validation
  9. Provide strategic scientific and operational advice to senior organization executives and aids the department head in establishing group goal objectives and budgets.
  10. May supervise supporting staff
  11. Performs other duties as required.

Desired Knowledge and Abilities:

  • Intact active scientific curiosity and excellent expertise in area of responsibility
  • Prefer experience working with both oral solid dosage form and sterile injectables
  • Understanding of Quality Systems and familiarity with industry standards and GMP/GCP/GLP requirements
  • Excellent organizational, interpersonal and managerial skills.
  • Well-developed scientific writing and communication skills.
  • Ability to present findings to cross functional groups in a clear and concise manner.

Education and Experience:
  • BS plus 4 years or MS degree plus 2 years of relevant Quality industry experience.
  • Hands-on experience managing and conducting external and internal audits including review of vendor responses and follow-up.