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
Seminars, Training and Professional Development
We're already interviewing, so don't miss out--apply today!
Applicants must be authorized to work in the U.S.