Director Quality Assurance – Team lead for early & late phase GMP manufacturing – Lexington, MA

Reference: SWI526D

Expiry Date: 30-03-2023

Categories Biotech, R & D

Salary: On Application

Job Type: Full Time

Middlesex County
United States

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Job Description

My colleagues and I are very excited to share with you with a brand-new position in a small R&D pharma working on early dev CGT medicines. This is a great opportunity to utilize your people leading and management skills as the QA GMP Director within a growing QA function at their in-house manufacturing facilities in Lexington, MA .  You will be surrounded by pro-active and committed professionals, as well as the senior management team (ex-Big-pharma), who all possess impressive experiences in CGT and other relevant therapy and research areas.

Applying for this position would be the right choice for you if you are looking for a smaller company with less hierarchy and more focus on science and creative decision making or you feel it’s time for a change, and you want to join a dynamic and intimate environment, where you will be given support and mentoring around your decision making and professional development.  You will be reporting into and supported by a highly accomplished Head of GXP, also on site and openly available.

To fill the role of GMP Quality Director, our client is looking for someone experienced in supporting technical services and overlooking technical agreements to collaborate with representatives from Supply Chain (SC), Quality Control (QC) and other teams in support of preclinical, clinical, and commercial product development. You will have Quality oversight of early and late phase GMP manufacturing activities internally and with external CMOs for drug substance and drug product and your team will be covering vendor management, internal audits, and quality systems. 

If you have been responsible for activities like CAPAs, change control, deviations, and providing direction and support of investigations within the last few years, this is your chance to lead a well-organized team (still growing) for a company just moving into Phase 3 with the next key stages being the preparation for an NDA and ultimately commercialization.

If you are looking for an expansive role where there is room to grow, and you can leverage your people management and your cGMP experience, my team and I would be happy to present you with more information.  You will be an accomplished QA professional, with years of leadership experience within pharmaceutical quality, with strong organizational skills, the ability to effectively multi-task and prioritize, and to adapt to changing business needs and meet timelines within a fast-paced environment.

Our client is offering a very competitive package with a strong salary, generous bonus, and excellent LTi/stock plan.


To Apply!

To apply for this role, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or send a full CV to and we will reply by return. We will support you throughout the interview and on-boarding experience.

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