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 Vice President, Quality Assurance that is responsible for in-house and outsourced activities supporting Rocket’s gene therapy programs. The incumbent will be responsible for all QA activities throughout the development lifecycle from preclinical through post-approval commercial production and testing.

• Lead and evolve the Quality function including Quality Assurance, Clinical Quality and Supplier Quality.
• Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment.
• Provide guidance and strategic direction for strategic decisions affecting quality assurance and compliance.
• Create and manage budgets effectively to ensure the allocation of resources in support of Rocket goals and objectives.
• Provide guidance on GCP activities and support development and implementation of a comprehensive quality framework including implementation of quality plans and related clinical processes/procedures.
• Support external GLP activities through protocol and report review
• Serve as Rocket’s Quality representative in Joint Steering Committee (or equivalent) arrangements with Contract Research and Development Organizations (CDMO)
• Provide QA oversight of activities associated with end-to-end manufacturing from raw material receipt inspection to shipment of final released drug product; provide oversight through audits and qualification process at CDMO’s.
• Ensure a state of inspection readiness and represent Rocket Quality as host of regulatory inspections internally and at applicable contract sites involved in GxP activities
• Use risk-based, science and compliance in decision making
• Author and review applicable CMC sections of filings, and as needed, interface with global health authorities. 

• 15 + years of experience with Bachelors degree or relevant experience in biological sciences or biotechnology OR 10 + years of relevant experience with Advanced degree in biological sciences or biotechnology
• Preference given to candidates with cell and gene therapy experience
• Demonstrated ability to interpret and apply pharmaceutical industry compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
• Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
• Ability to effectively lead and resolve quality issues
• Ability to develop and execute strategies
• Handle issues appropriately and with a sense of urgency
• Strong leadership to support a multi-project environment in small biotech or large pharma
• Ability to interact, cooperate and motivate across departments and functions

The expected salary range for this position is $294,000 to $352,000.

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).

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.