We are currently supporting a global contract development and manufacturing organization (CDMO) in their search for a Manager of Manufacturing Quality Assurance. This role is based at a growing facility which plays a key role in the development and production of sterile pharmaceutical products.
The successful candidate will be responsible for overseeing all floor-based QA operations within a GMP-regulated manufacturing environment. This is a high-visibility position that will serve as the primary Quality Assurance contact for sterile product manufacturing and will play a critical role in ensuring compliance, product quality, and operational excellence.
Key Responsibilities:
- Lead and manage day-to-day QA oversight of sterile manufacturing operations, including batch record review, in-process inspections, and on-the-floor support.
- Serve as the QA representative for production activities, validation, and investigations.
- Support internal quality systems, including change control, deviations, CAPAs, and risk management initiatives.
- Hire, train, and develop a team of Manufacturing Quality Assurance (MQA) professionals.
- Interface with internal departments and clients on matters related to product quality and compliance.
- Participate in internal and regulatory audits as needed.
- Support continuous improvement initiatives aligned with corporate quality standards.
Candidate Requirements:
- Minimum of 5 years of experience in Quality Assurance or Regulatory Affairs within a GMP-compliant, sterile pharmaceutical manufacturing environment.
- At least 2 years of experience in a leadership or supervisory capacity.
- Strong working knowledge of FDA regulations, cGMPs, and quality system requirements.
- Experience with sterile or aseptic manufacturing processes is essential.
- Proven ability to manage batch record review, investigations, and quality documentation.
- Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field).
Preferred Experience:
- Experience working within a CDMO or contract manufacturing setting.
- Knowledge of 21 CFR Part 11, aseptic processing techniques, and pharmaceutical inspection readiness.
- Familiarity with client-facing responsibilities in a regulated environment.
Additional Information:
This role offers a unique opportunity to join a site that is actively investing in growth, including expanded sterile manufacturing capabilities. The environment is collaborative, fast-paced, and offers strong long-term career development potential for individuals with a hands-on, proactive leadership style.
Featured benefits
- 401(k)
- Dental insurance
- Medical insurance
- Vision insurance
