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 an Associate Director Quality Assurance with the responsibilities to work with SMEs for development of process validation plan, evaluate process performance, product quality for the manufacturing of a range of Gene Therapy products. The incumbent will be responsible to ensure of the quality assurance of all CMOs sites that are working with Rocket Pharma conform to the pharmaceutical quality standards and the regulatory authorities (FDA & EMA). The incumbent will also be responsible to identify and assess regulatory and quality risks within the manufacturing processes of the company’s diverse programs.
- Assess the status of the company’s current Quality Systems procedures according to regulatory guidelines and compliance requirements to identify the gaps and develop a plan for implementation
- Author, revise and review SOPs that govern Rocket Pharma’s manufacturing Operations
- Develop and establish a master validation plan for the company
- Ensure that that process validation of Rocket Pharma programs are executed in accordance with current guidelines and meet regulatory requirements of EMA and FDA
- Manage the Quality Assurance of all activities during the production of clinical and future commercial Gene therapy products (Starting Materials, Reagents, Media and all components used in the manufacture processes)
- Develop productive relationships with CMOs/CTOs for all products and projects
- Review batch record documentation for disposition
- Oversee the release process of stating materials, drug substance and all other components before use in production
- Work with cross functional peers to meet company’s deadlines
- Support filing activities for IND and CTA-enabling to commercial programs for multiple gene therapy products.
- Ensures change controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Conduct effective root cause analysis and implement corrective action and preventive action
- Manage the Deviation and CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
- Host and support regulatory inspections, audit plan
- Review protocols, data summaries, reports for stability studies and validation
- Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address risks.
- Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections and Annual Reports
- Assure that all manufacturing records (testing, methods, protocols, reports) are generated, approved and managed
Education/Experience and Skills Requirements:
- 10 + years with BS of relevant experience in biological sciences or biotechnology industry
- 8 + years of experience with MS degree in biological sciences or biotechnology industry
- 4+ of experience with Gene/Cell therapy products for clinical and commercial
- Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory 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
Location: New York, NY / Cranbury, NJ
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.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Search Firm Representatives Please Read Carefully
Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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