Job Title: Manager/Senior Manager of Quality Control
Reports To: Director, Quality Assurance
Location: Boston, MA
The Manager of Quality Control is responsible for providing vision, strategic and operational leadership for both drug substance and drug product. Lead efforts to meet company objectives through manufacturing and development support, including product quality testing, method validation, method transfer, control strategy development, and stability testing. The incumbent is responsible for ensuring all company, regional, and global standards and regulations are met, and that the department is developed and maintained to a standard that ensures the quality of products and materials produced by our contracted partners. Assist with all CMC Quality activities in preparation of the Phases 1-3 and Commercialization (NDA filing).
This role reports to the Director of Quality Assurance and is based in Boston, MA. Starting date is flexible.
What makes this role special:
- Seek to have a profound impact on young children and their families
- Potentially be part of the first launch of a medicine for a rare pediatric liver disease
- Work on a portfolio of multiple potential therapies
- Gain a rare diversity of commercial experience
- Develop strategy, as well as manage execution
- Help shape the culture and future of an emerging biopharma with a big vision
- Collaborate with a small, collegial team of good people
- Learn from leadership with deep experience and a history of success
- Be part of an early biopharma company in an excellent financial position
- Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment
Responsibilities (may vary): This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.
Key Duties and Responsibilities:
- Lead efforts to ensure manufacturing and testing organizations (CMOs and test labs) are operating in a manner that is consistent with regulations and internal policies.
- Provide analytical oversight of all in-process, raw material, and final product testing. Review batch records and associated data to ensure all approved procedures were followed and all specifications were met. Track all non-compliance events that occur during production and testing.
- Review all stability testing data performed for Albireo. Establish trends, follow up on all testing non-conformance events, and ensure data is analyzed to help understand the process, formulation and degradation pathways.
- Ensure contract service providers (i.e. CMOs, CTOs, etc) adhere to strict data integrity regulatory policies and provide constant oversight of CSP operations to confirm data is ALCOA (accurate, legible, Contemporaneous, original, Attributable) and traceable to the raw data source.
- Lead efforts to establish data to support control strategies for manufacture processes and the understanding of those processes.
- Oversee management of the reference standard program at each CMO and test lab.
- Assist in efforts to oversee method validation and transfer of methods in coordination with Albireo CMC/Analytical and CMO/CTO Analytical. Work with Analytical and CMOs to establish method suitability through proper testing and documentation.
- Review and approval all protocols associated with stability, method validation and method transfer.
- Review and approve labeling and packaging batch records and specifications
- Review and approve batch records for all labeling and packaging operations. Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
- Assure that source data and information is maintained and traceable. Maintain appropriate documentation to demonstrate the review and acceptance of the test data.
- Contribute to appropriate sections of Annual Product Review for applicable products
- Contribute and help organize reviewed manufacturing information and data for inclusion in regulatory filings (CTD/NDA/BLA or IND)
- Explore ways to identify quality improvements to Quality Systems to maintain compliance and improve efficiency as part of continuous improvement initiatives
- Assist with the inspection and evaluation of Quality Unit (QU) business model for moving to Phase 3 and Commercialization.
- Assist with conducting internal QC checks and reviews of the data generated by the Contract Sites
- Review and evaluate Batch Production and Control Records for API and Drug Product , including data generated by different functions and accordingly approve the release of finished product
- B.S. or M.S. in Life Sciences or related science degree required (Additional experience may be substituted for the advance degree)
- Minimum (5) years of experience in QC and/or Analytical Quality within the Pharmaceutical or Biotechnology industry
- Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations.
- Good understanding of product process and development, from discovery to commercialization
- Knowledgeable with phase-appropriate CGMP regulations and ICH or other industry guidance.
- Experience with the CMC and Regulatory Filing requirements
- Small molecule experience