Senior Auditor, Supplier Quality

Cranbury, NJ /
Quality – Quality Assurance /
Full Time
/ Remote
Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

We are seeking a motivated Sr. Auditor, Supplier Quality who will perform audits to assure the quality of products, raw materials, services, and data provided to Rocket by raw material suppliers, service providers, clinical trial sites, and contract development and manufacturing organizations (CDMOs). This is a key role in the continued expansion of Rocket Pharma’s GMP operations, providing our professionals with the understanding and tools they need to achieve our high standards of quality and compliance. Curiosity, positivity, and goal-orientation are key success factors for this role.

Responsibilities:

    • Develop risk- and performance-based audit plans, agendas, and questionnaires.  Perform on-site and remote GxP compliance audits of GxP service providers and contract manufacturing, testing, and clinical trial sites and locations.
    • Maintain an up-to-date view of supplier qualification status through Rocket’s Enterprise Resource Planning (ERP) and electronic Quality Management Systems, maintaining all audit plans, findings, reports, and follow-up audits and activities.
    • Prepare supplier performance metrics and reports to inform Senior Management of compliance and business risks.
    • Ensure Quality Agreements and other technical and legal arrangements with suppliers are clear, comprehensive, and enforced.
    • Assist suppliers in Quality Risk Management activities, including deviation investigations, change management to ensure compliance with regulatory commitments and requirements.
    • Conduct reviews of documents and supporting records from client organizations, including batch records, quality control testing records, protocols, reports, and other documentation, elevating and resolving questions and discrepancies with the supplier.
    • Support an environment of continuous improvement with an emphasis on relationship management, shared accountability, and open communication. 
    • Actively promote data governance best practices and work actively across the supplier network to adopt quality plans or related strategies to ensure data integrity in all Rocket-sponsored activities.  
    • Assist with regulatory inspections and inspection readiness activities.
    • As required, independently plan, conduct, lead, and/or participate in internal audits.
    • Benchmark to ensure processes, systems, and Rocket Quality Standards are consistent with current GxP and industry best practices.

Requirements:

    • Bachelor’s Degree in Life Sciences or Engineering or equivalent relevant career experience.
    • 8+ years of relevant GMP experience in pharma/biotech company, with at least 5+ years of experience leading and facilitating audits and 1+ year managing a supplier quality program.
    • Knowledge of Biologics, Cell Therapy and/or Gene Therapy, with hands-on manufacturing or testing experience a plus.
    • Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
    • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
    • Must be able to correctly identify and prioritize risk in the context of patient safety and compliance.
    • Detail-oriented with expert knowledge of cGMP regulations, as well as ATMP regulations, and the ability to use this knowledge to determine appropriate remediation strategies.
    • Ability to make independent and objective decisions, and to work with minimal supervision.
    • Must possess an independent mindset and tenacity.
    • Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
    • Ability to work effectively across functional groups and teams to ensure requirements and timelines are met.
    • Excellent verbal and communication skills
    • Travel Requirements - 30-40% domestic and international travel
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.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.