Director, Quality Assurance- LVV
Cranbury, NJ /
Quality – Quality Assurance /
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 Director, Quality Assurance responsible for the oversight and management of outsourced activities supporting Rocket’s ex-vivo lentivirus programs. The incumbent will be responsible for working with Contract Manufacturing and Development Organizations (CDMOs) to maintain and improve their compliance with Rocket’s pharmaceutical quality standards and regulatory authority expectations (FDA & EMA). The incumbent will also be responsible for identifying and mitigating product quality and regulatory compliance risks across the CDMO network.
- Monitor performance and continuously improve the efficiency, and effectiveness of programs for managing Contract Manufacturing and Development Organizations (CDMOs).
- Provide guidance to CDMO’s in effective and timely resolution of deviation/investigations.
- Assess change controls for risks and impact on processes, products, and programs.
- Serve as QA reviewer/approver for development reports, change requests, product specifications, product labeling, and other key documents.
- Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance.
- Assist with preparation for FDA and other regulatory inspections.
- Develop and execute inspection readiness plans for key CDMOs.
- Review raw data and data summaries presented in internal reports and regulatory submissions.
- Work with subject matter experts to define and implement process and procedure improvements.
- Perform and coordinate reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities.
- Support supplier quality management activities, including audits, quality agreement review, and performance management activities.
- Author, review and approve procedures that govern CDMO operations.
- BS with 15 years of relevant experience in biological sciences or biotechnology.
- 8 + years of experience with advanced degree in biological sciences or biotechnology.
- Preference given to candidates with cell and gene therapy and CDMO 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.
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.