Rx Group is supporting a global Biotech based in New Jersey with a Senior Director, Product Quality to join them on a full-time basis. The role requires some travel, but can largely be done remotely.
Position Overview:
The Senior Director, Product Quality, will be responsible for end-to-end product quality strategy for new product classes or technical areas, with a particular focus on cell therapy, large molecules, and small molecules. This role will cover product quality oversight from preclinical stages through pivotal clinical trials, regulatory filings, and commercial launch, ensuring robust supply and patient safety.
The role requires strong collaboration with cross-functional teams across CMC, including Manufacturing, Process Development, Analytical Development, MSAT, and Supply Chain, to ensure that product quality standards are met in compliance with regulatory requirements. The ideal candidate will possess extensive knowledge of the full CMC process, technical expertise in cell therapy, and the ability to influence and guide cross-functional teams in a matrix environment.
Key Responsibilities:
- Product Quality Strategy: Lead the product quality strategy for one or more new modalities, ensuring end-to-end quality plans are developed from preclinical stages through commercial launch, supporting accelerated and reliable supply to patients.
- Cross-functional Collaboration: Partner closely with Manufacturing, Process Development, Analytical Development, MSAT, Supply Chain, and CMC leadership to ensure quality standards are maintained across all stages of product development and manufacturing.
- Technical and Regulatory Oversight: Provide product quality oversight during product development, analytical development, characterization, tech transfer, comparability, and validation studies.
- Regulatory Filings: Author, review, and provide technical support for regulatory documents (IND, IMPD, BLA, MAA) and ensure compliance with ICH Quality Guidelines, cGMPs, CFRs, and global regulatory requirements.
- Issue Resolution: Provide expert-level support for technical issues arising during routine manufacturing and distribution, ensuring product quality is maintained at all times.
- Governance and Leadership: Lead governance forums and cross-functional oversight, providing strategic direction to ensure timely product development, regulatory success, and product launch.
- Mentorship: Support and mentor junior staff, and collaborate with the Global Head of Product Quality to provide guidance on product and analytical development strategies, process improvements, and new product development.
- Continuous Improvement: Stay up-to-date on industry trends, regulatory changes, and new technologies to improve quality systems and processes.
Qualifications:
- Advanced degree (M.S. or Ph.D.) in Life Sciences, Engineering, or a related field.
- At least 14 years of experience in pharmaceutical or biopharmaceutical manufacturing, with a strong focus on quality operations.
- Extensive knowledge of CMC processes and quality requirements, especially in cell and gene therapy, large molecules, and small molecules.
- Proven experience in new product development, tech transfer, and comparability assessments, with a focus on ensuring product quality and regulatory compliance.
- Strong familiarity with global regulatory guidelines, including ICH Quality Guidelines, cGMP, CFRs, EC/JP GMPs.
- Experience working in a matrix environment, with the ability to lead and influence cross-functional teams without direct authority.
- Excellent communication skills and the ability to simplify complex technical information for a broader audience.
- Experience in regulatory filings (IND, IMPD, BLA, MAA) and providing technical support for regulatory submissions.
- Demonstrated leadership skills with the ability to engage and motivate cross-functional teams.
What is on Offer:
- The opportunity to work on cutting-edge therapies that will have a real impact on patients' lives.
- Competitive salary and benefits package.
- Collaborative and innovative work environment with strong emphasis on teamwork.
- Career development opportunities in a fast-paced, dynamic biotech company.
If you are interested, please apply or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for more information.
