This position is responsible for quality and compliance oversight of manufacturing, packaging, testing and distribution in operations that support global distribution of BBI products including small molecules, peptides and drug delivery devices. This includes oversight of active pharmaceutical ingredient (API) manufacturing operations as well as dosage form manufacturing operations including capsules, tablets and aseptically lyophilized drug product. Familiarity with international current good manufacturing practices (cGMPs) for both drug and devices and other best practices for pharmaceutical manufacturing operations will be a critical component of this role. This Quality function supports early and late stage clinical programs as well as NDA filing and commercial drug launch. The role will partner with internal stakeholders to ensure that Quality supports CMC and other cross functional teams as well as the Company’s processes.
- Primary Quality contact/interface with Contract Manufacturing Organizations (CMOs) and partners that are based in the US, Japan and other global locations
- Responsible for release of drug substance and drug product as well as any starting materials or intermediates, as required
- Responsible for assessing and approving deviations, investigations and leading CMC related change control reviews
- Leads Specification and Stability Committee meetings to collaboratively set product standards
- Responsible for reviewing and approving analytical method and process validation protocols and reports, and for coordinating analytical method transfer activities
- Conducts audits of CMOs, global distribution depots, suppliers of critical services
- Responsible for developing and maintaining Quality Technical Agreements
- Primary contact with partner companies regarding quality matters
- Responsible for serving as person-in-the-plant when needed
- Writes and reviews CMC sections as needed for regulatory submissions
- Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.
- Provide oversight on deviations, investigations, CAPA, change control, complaint document and record control as related to manufacturing operations.
- Manages personnel in all accountable departments with a focus on retention and development. Manages contract and consultant personnel to BBI standards.
- Support a culture of quality and collaboration across the company.
- Monitors industry trends and regulatory intelligence to ensure evolution of the CMC compliance strategy.
- Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.
- Assist in the management of regulatory agency inspections both at BBI and the CMO.
- Facilitates compliance reviews of technical documentation for FDA marketing applications.
- Establishes the timely, proficient identification, analysis and strategy for addressing the quality/compliance related aspects of key development programs and or manufacturing issues.
- Other duties as needed.
- Bachelor’s degree in Biology, Chemistry, Engineering or related scientific discipline required; Advanced degree (MS, PhD, MBA) preferred.
- 15+ years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a leadership role.
- Quality experience working in an API and/or dosage form clinical and commercial manufacturing, packaging and testing environment for small molecules and large aseptically processed molecules
- Must have experience with electronic document management and quality systems, iStability, Veeva and Master Control a plus
- Must have in-depth knowledge of FDA and international guidelines and have a proven track record in implementing these guidelines in fast growing environments.
- Experience in evolving cGMP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
- Demonstrated leadership successes in building and creating functions and infrastructure.
- Experience with external CMO and contract laboratories as a part of a virtual company
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Drug/Device Combination Product experience desired
- Experience with Oncology drugs desired
- International experience a plus, especially Asia and Europe
- Possess strong conflict management and negotiation skills.
- Excellent verbal and written communication skills
- Self-motivated, able to work independently and be reliable and responsive
- Travel domestic and international approximately 25%
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org
Equal Opportunity Employer