About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
The Sr. Manager, Quality Assurance for Quality Control manages contract testing organizations (CTOs) for all activities associated with Quality Control operation of in-process and release testing for raw materials, starting materials, and drug products in support of our commercial operations.
This position requires close partnering with the CTOs as well as the internal cross-functional teams. The role will provide a significant contribution to the process of sample submission for release testing to Certificate of Analysis (COA) approval. Responsibilities include but are not limited to: ownership and management of quality systems (deviations, change controls, laboratory investigations, and corrective and preventative actions (CAPAs), facilitating meetings both internally and externally with CTO partners including joint management forums and risk assessments to support CTO facing change management and regulatory filings. Additionally, this person will be responsible for managing the stability program for all three commercial products, including data management, regulatory support.
Job Duties and Responsibilities:
- Manage Quality Control related communications within CTOs and contract manufacturing organizations (CMOs)
- Lead the Stability program focusing on our annual commitment and regulatory filings
- Build on relationships within our CTOs and CMOs ensuring issues impacting Quality Control testing are tracked and resolved in a timely manner
- Own and/or support current good manufacturing practice (cGMP) routine testing by owning quality systems required for deviations, laboratory investigations, and CAPAs
- Lead and/or collaborate with the internal cross-functional team and/or CxOs to review and perform documentation of deviations, laboratory investigations, and CAPAs
- Participate and provide updates on Quality Control lot status at various internal forums
- Lead, support, and mentor other members of the team with any activities related to the responsibilities of this role
- Support process improvement initiatives across the quality department
- Ensure all documentation complies with cGMP regulations and industry guidelines
Essential/Required Qualifications:
- BS or MS in a scientific discipline with 5–10+ years of experience in a QC cGMP clinical and/or commercial environment
- Experience managing CTOs and CMOs, with strong interpersonal and partner-management skills
- Stability program management experience, including familiarity with ICH guidelines
- Direct people-management experience, including management of teams or individual contributors
- Excellent organizational skills and the ability to succeed in a fast-paced environment
- Experience with quality systems supporting deviations, laboratory investigations, and CAPAs
- Strong working knowledge of cGMP, ICH, FDA, and EMA regulations
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
