Director of Quality Assurance, Commercial GMP
4 weeks ago
Location: Lexington office. Hybrid schedule: 4 days in-office, 1 day remote.
If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.
As the Associate Director of Quality Assurance GMP, reporting to the Executive Director, Quality, you'll manage GMP quality standards for clinical-stage programs. This includes overseeing production at internal Manufacturing Laboratory and with contracted service providers, covering cell banks, drug substance, drug product, and labeled drug product. Working closely with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other teams, you'll ensure phase-appropriate solutions are implemented to uphold patient safety, support program advancement from clinical development to commercialization, and enhance operational efficiency.
Responsibilities include:
- Leading Quality Assurance in cross-functional teams across product development, technology transfer, and regulatory dossier preparation.
- Supervising and nurturing a team of QA professionals to promote their growth.
- Establishing and enhancing procedures for GMP manufacturing of clinical materials.
- Implementing quality systems such as deviation management, CAPA, and change control.
- Preparing for and managing regulatory inspections and external audits.
- Conducting on-site oversight at Contract Manufacturing Organizations (CMOs).
Qualifications:
- 8+ years in regulated pharmaceutical settings, with 3+ years focused on Quality Assurance.
- Bachelor's degree in science, engineering, biochemistry, or related fields, or equivalent qualification.
- Thorough understanding of US and EU CGMP regulations and guidelines.
- Expertise in QA/QC, Manufacturing, and Supply Chain operations.
To find out more, please contact Patricia Sousa (patricia.Sousa@lifescirecruitment.com)
At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups, fast-growing biotech and pharmaceutical organisations.
Founded in 2021, we recognised the need for a company with the insights, knowledge and credibility of a search firm but offering a contingent service.
As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought after candidates to fit your requirements ranging from temporary placement to Fortune 500 companies
LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm.
Contact us today to learn more about our recruitment services.
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