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

Additional Information

The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.

Pay Transparency

$145,000-$196,000 USD