Senior Manager - Quality Assurance - GMP

About the Department                                                                                                                                    

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

 

The Position

This position supports clinical development Quality Operations for small molecule products. The position is focused on GMP manufacturing, including investigation/CAPA, change control, and lot release.

 

Relationships

The role reports to a Director of QA GMP.  Candidate will interact daily with process chemists, formulation development, analytical and QC SMEs based in the Watertown, MA site, and also with similar SMEs and QA at our Contract Development Manufacturing Organizations (CDMO)s.

The role is an individual contributor, though the person may be asked to manage contingent workers as a backup to their manager.

 

Essential Functions

• CDMO oversight
  • Primary Quality contact for assigned external vendors supporting Clinical Program(s) (Starting Materials, API, Drug Product Intermediate, Drug Product and/or Finished Goods)
  • Ensure appropriate Qualification of vendors and monitor ongoing compliance of operations
  • Oversight of the external activities associated with manufacturing, disposition, and distribution of clinical materials
  • Monitor performance of vendors to evaluate and mitigate program and compliance risk(s) and escalating quality issues as needed
  • Establish and maintain Quality Agreements in support of clinical operations at vendors
• Lot Disposition/Release
  • Master and Executed batch record review and resolution of comments and issues
  • Evaluate, Review and Approve change controls in support of program requirements
  • Execute lot disposition activities (including working with Qualified Person) to ensure that materials are released in accordance with regulatory requirements, cGMPs and policies and procedures and within project lead times
  • Perform Quality review of analytical documentation for CMC programs, including method validation protocols/reports, in-process data, lot release data packets, certificate of analysis, stability protocols/reports
  • Participate as an active team member on in-house cross functional and CMC teams (i.e., Quality, Pharmaceutical Sciences, Regulatory, Clinical Operations, etc.) to provide compliance guidance
  • Interface with internal departments and external vendors on a variety of technical/quality subjects
  • Participate in root cause analysis and develop project plans and/or corrective action that may impact multiple functions (including external Vendors)
  • Escalate issues to management as applicable.

• Support the local Quality Management Systems
  • Contribute to continuous improvement initiatives
  • Address compliance gaps and provide input to process changes
  • Maintain and record accurate batch metrics in support of Quality Management Review
  • Provide vendor management and performance oversight

 

Physical Requirements

Approximately 10-20% overnight travel, occasionally international.

 

Qualifications

• BS Degree in Chemistry, Pharmacy, Biology or a related life science or a combination of a BS Degree with relevant Quality and Technical experience
• Minimum of 7+ years of experience within the