Senior Director, Quality Control
About The Position
Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a Sr. Director, Quality Control with the responsibility of supporting clinical and commercial manufacturing for a range of AAV and LVV gene therapy products. The candidate will be responsible for leading the Quality Control function while building and maintaining relationships with key stakeholders. In addition, the candidate will be accountable for the oversight of all QC testing activities both internally and externally as well as maintaining GMP compliance across all laboratory operations. The position will report in the Vice President, Technical Operations.
Requirements
- PhD. in Molecular Biology, Cell Biology, Immunology, or related field with 15 years of experience in GMP/QC environment or equivalent experience in the biotechnology industry; M.S. with 12 years of experience GMP/QC environment or BS with 15 years of experience GMP/QC environment.
- Minimum of ten (10) years of leadership experience required.
- Experience with Gene/Cell therapy products (CART-Therapies) for clinical and commercial.
- Strong experience with method validation and/or method transfer required.
- Expert knowledge of GMPs & compendia requirements (USP/EP/JP) required.
- Experience interacting with regulatory health authorities at pre- and post-approval inspection.
- Experience supporting all phases of a program’s lifecycle (pre-IND through commercial lifecycle management).
- Experience authoring CMC sections of regulatory submissions.
- Strong abilities in scientific analysis and writing.
Responsibilities
- Establish and execute the QC strategy ensuring alignment with company objectives, regulatory expectations, and product lifecycle stage.
- Provide leadership and oversight of Quality Control operations while fostering a collaborative, high-performing, and engaged organization.
- Drive process excellence and right-first-time execution through the implementation of First Time Right initiatives.
- Oversee all QC testing activities internally and externally, including Analytical, Microbiology, Environmental Monitoring, Stability, and Raw Materials.
- Coordinate management structure of the laboratory to build Analytical datasets (release and stability, analytical validation) for Starting Materials, DS and DP so they are readily available to support CMC and all Regulatory filings (IND/BLA).
- Provide scientific oversight for method development, qualification, and validation.
- Ensure GMP compliance across laboratory operations, including systems and equipment, and uphold data integrity principles.
- Oversee critical investigations (e.g., failures and CAPAs), ensuring thorough root cause analysis and effective corrective and preventive actions.
- Track and analyze cGMP data, identify trends, and monitor key performance metrics to optimize laboratory quality, productivity, and readiness for management reviews and Annual Product Reviews.
- Foster strong cross-functional partnerships with Technical Operations, Technical Development, Quality Assurance, and Program Management to execute strategic initiatives and drive organizational success.
- Develop strategy for external lab service providers and Contract Lab Services plus review and approve Quality Agreements for all external lab services.
Benefits
- Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
- In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
