Cambridge, United States
about 2 years ago
Director, Quality Control- Raw Materials
- The Director of Raw Materials is responsible for managing and development of the raw materials program strategy and associated policies. This role will collaborate with cross-functional teams to harmonize RM programs across various sites. This position will collaborate cross-functionally with Clients, Supply Chain, QA, and Manufacturing on vendor selection and qualification. They will also be a lead in RM risk assessments as a subject matter expert The Director of Raw Materials will monitor and create mitigation plans for compendial and/or regulatory requirements as it relates to raw materials. This function will be responsible to author, review, and/or approve SOPs, policies, risk assessments, and technical reports.
- Directs team to develop best practices to identify and remediate any capacity constraints. Creates raw materials strategy that reduces lead times and help build programs that build speed capabilities to give agility.
- Provide technical expertise to sampling and testing of raw material. Review/analyze testing protocols generated by CTLs for completeness and accuracy. Submit documentation for QA review. Communicate these activities to BB Clients and Management as needed. Ensure that these activities meet project and production objectives on time.
- Develop, execute and ensure compliance to procedures. Review and approve deviations/ investigations from CTLs; prepare tandem in-house investigation/ deviation reports. Assist in developing metric parameters to evaluate and monitor performance of CTLs.
- Develop strategies for evaluating and selecting CTLs, managing outsourced testing needs, timelines, risk mitigation and business priorities. Perform quality audits of CTLs for compliance. Work closely with staff responsible for preparation and shipment of samples to CTLs to ensure timelines met and samples are maintained in the appropriate condition. Communicate these activities to BB Clients and Management as needed. Ensure that these activities meet project and production objectives on time.
- Bachelor's degree in life sciences and ten years of appropriate experience required. Advanced degree in life sciences a plus. The ideal candidate will have a degree in Biology, Microbiology or Cell/Molecular Biology, or related field with strong background in raw material management.
- Working knowledge of GLP/GMP laboratory procedures with emphasis on raw material testing requirements and regulatory expectations as it pertains to raw materials. QA or QC experience in gene therapy analytical testing and development is recommended.
- Strong aptitude managing projects utilizing PMI principles (PMP not required, but preferred) and the ability to communicate effectively, proactively and professionally to clients and members of the management team.
- Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and Project programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.