Senior Director Product Quality Lead

3 days ago

Reston, Virginia, United States Rx Group Full time
Senior Director Product Quality

Rx Group is seeking a highly experienced Senior Director Product Quality to join their team. This role will be responsible for leading the product quality strategy for new product classes or technical areas, with a focus on cell therapy, large molecules, and small molecules.

Key Responsibilities:
  • Develop and implement product quality strategies to ensure end-to-end quality plans are developed from preclinical stages through commercial launch.
  • Collaborate with cross-functional teams to ensure quality standards are maintained across all stages of product development and manufacturing.
  • Provide technical and regulatory oversight during product development, analytical development, characterization, tech transfer, comparability, and validation studies.
  • 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.
  • Provide expert-level support for technical issues arising during routine manufacturing and distribution, ensuring product quality is maintained at all times.
  • Lead governance forums and cross-functional oversight, providing strategic direction to ensure timely product development, regulatory success, and product launch.
  • 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.
  • 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 We 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.

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