Associate Director, Product Quality- Remote
Led by our team of seasoned drug developers and immunotherapy trailblazers, our Boston based biotech client who is leveraging gene editing to engineer novel T cell therapies is looking to add an Associate Director of Product Quality to their team
The candidate will be responsible for providing quality review and oversight for each stage of analytical and process-related activities throughout the product development lifecycle, ensuring adherence to relevant regulations, industry standards, and company policies. This position will work closely with cross-functional teams throughout the product development lifecycle and requires the candidate to have strong CMC experience.
The major tasks for this position are as follows:
- Provide quality review and oversight for each stage of analytical and process-related activities during the product development lifecycle, ensuring adherence to relevant regulations, industry standards, and company policies.
- Participate as a Person in Plant (PIP) by overseeing the Contract Manufacturing Organization’s (CMO) manufacturing, testing, and additional operations to guarantee adherence to quality standards, Good Manufacturing Practices (GMP), and other applicable regulations.
- Monitor and assess the performance of contract manufacturing organizations (CMOs) to ensure that they meet the required quality standards and expectations.
- Review batch records initiated from a CMO for accuracy, completeness, and compliance with regulatory requirements and internal policies.
- Provide quality review of deviation and change controls to ensure timely and appropriate resolution of issues and compliance with regulatory requirements and internal policies.
- Conduct quality review and oversight of lifecycle documentation that supports regulatory submission
- Lead and participate in internal and external audits, inspections, and regulatory agency interactions, ensuring timely and appropriate responses to findings and observation.
Education and Experience:
- Bachelor’s degree in Life Sciences, Biotechnology, or a related field; advanced degree preferred.
- 10+ years of experience in Quality Assurance within the biotech or pharmaceutical industry, with a focus on CMC analytical and process-related activities.
- In-depth knowledge of regulatory requirements and industry standards, including FDA, EMA, ICH, GMP, GLP, and GCP.
- Strong experience in managing quality assurance activities during the product development lifecycle, from preclinical research to clinical trials and commercialization.
- Proven track record of successful collaboration with cross-functional teams and external partners, such as CROs and CMOs.
- Excellent communication, leadership, and problem-solving skills.
- Ability to work in a fast-paced, dynamic start-up environment and adapt to changing priorities.
Send your CV or resume to: firstname.lastname@example.org