Director, QA for QC
$213,063–$260,411 year
HybridCambridge, Massachusetts, United States
Job Summary
Provide strategic and operational quality oversight for QC activities supporting the development, manufacture, testing, release, and lifecycle management of gene editing products. Establish and mature trending and predictive quality capabilities using stability, routine release, and in-process testing data while ensuring outsourced testing operations comply with global GMP regulations. Act as the primary Quality authority for compliance, investigation oversight, stability programs, and test method governance, partnering closely with Analytical Development, Process Development, and Regulatory Affairs. Recruit, interview, and train new QA staff; oversee daily department workflows; and mentor personnel transitioning from clinical to commercial GMP operations. Lead QA audits and regulatory inspections, driving continuous improvement initiatives across QC processes and analytical efficiency.
Required Qualifications
- Prior experience with direct or indirect oversight of employees
- Knowledge of the use and interpretation of FDA and ICH regulatory guidelines and pharmacopeias such as USP/NF, EP, and JP
- Knowledge and experience with electronic systems such as EDMS, LIMS, etc.
- Prior experience with requirements for stability in the pharmaceutical industry and generation of in-house reference standards
- Experience with data analysis software such as JMP, MINITAB, GraphPad Prism, PLA, etc.
- Detail oriented and able to manage multiple, competing priorities and have strong verbal and written communication skills and delegation of the tasks within a team
- Technical understanding of analytical techniques, including HPLC/UPLC, CE, compendial, UV, bioassay and gel electrophoresis
- Strong leadership qualities including strategic thinking, innovation, mentoring and collaboration
- Excellent written and verbal communication skills
- Excellent organizational skills and attention to detail
- Strong analytical and problem-solving skills
- Advanced degree in Chemistry, Molecular/Cell Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline
- MS/PhD preferred
- 10-12 years of relevant industry experience
- Experience in phase appropriate GMP testing, and Lab Operations of cell/gene therapies or biologics
- Expertise in qualification, validation, transfer and life cycle management of analytical methods
- Experience in Health Authority Inspections, related observations and implementation of CAPAs
- Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
- Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
- Experience with IND or BLA filing of ATMP/biologic products
- Experience with commercial QC activities
- Must be available for hybrid work (implied by #LI-Hybrid and management of remote/hybrid expectations)
Desired Qualifications
- Advanced degree in Chemistry, Molecular/Cell Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline (MS/PhD preferred)
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