Senior Director, Quality Control

Overview Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life‑threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary 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 Senior 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. 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. Qualifications 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. Compensation The expected salary range for this position is $232,000 to $277,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world‑class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at‑will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. 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). EEO Statement A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws. #J-18808-Ljbffr Rocket Pharma