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Director Of Quality Assurance GMP

Expired Job

Cybercoders Cambridge , MA 02138

Posted 5 months ago

Clinical-stage, well-funded biotech company in Cambridge impacting life-altering diseases through novel immunology therapeutics is hiring their first Director of Quality Assurance to lead the implementation of quality systems.

If you are a Quality Assurance Director or QA Associate Director with experience leading quality systems for internal or external clinical and/or commercial manufacturing of peptides, small molecules, or combination devices / parenterals, please read on!

This is a new, direct-hire position created due to company growth. Potential for relocation assistance.
Top Reasons to Work with Us

  • Quality-oriented culture that starts at the top with the CEO!

  • 5 diverse programs in our pipeline with 2 already in phase II!

  • Uniquely positioned to apply immunotherapy to auto-immune and inflammatory diseases.

  • Since we're small, you'll have the opportunity to have a huge impact in our fast-paced environment!
    What You Will Be Doing

Our upper-level management is prioritizing quality and we are ready to hire the right person to build out our quality systems!

  • Design and implement new quality systems, processes, and procedures.

  • Train staff on new quality systems.

  • QA document control as needed.

  • Internal and external audits (we may decide to outsource the external audits)

  • QA oversight (CAPAs, deviations, etc.) for external suppliers and vendors / CMOs manufacturing peptides and combination devices / parenterals

  • Approve or refine clinical investigation medicinal product label text and proofs

  • Operate and manage change control programs
    What You Need for this Position


  • BA/BS with experience leading and driving quality assurance systems, processes, and procedures strategy and implementation

  • QA oversight of GMP manufacturing of peptides, small molecules or combination devices / parenterals (biologics may be considered)

  • Openness to perform high-level (strategic, etc.) and low-level (doc control, etc.) work as needed in our growing environment as we scale up

  • Strong knowledge of US, EU, and ICH GMP requirements
    What's In It for You

Paid parking or public transit allowance

Competitive Salary

Relocation Assistance

Stock Options

Great Benefits

Generous PTO/Vacation

Seminars, Training and Professional Development

Advancement Opportunities

Paid Holidays
We're already interviewing, so don't miss out--apply today!

Applicants must be authorized to work in the U.S.

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Director Of Quality Assurance GMP

Expired Job