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Director of Cell and Gene Product Quality
hace 4 semanas
The Director of Product Quality will oversee quality strategies for cell and genetic programs throughout clinical development, commercialization, product launch, and post-approval lifecycle management activities. This role will set and maintain overall Quality standards, collaborate with key stakeholders, and ensure internal and cross-functional alignment with industry and regulatory expectations.
Key Responsibilities- Lead the development and implementation of CMC Quality standards for products and processes.
- Collaborate with internal and external stakeholders to ensure quality and compliance frameworks are in place.
- Drive manufacturing and compliance continuous improvements throughout the commercial life cycle.
- Proactively identify Quality risks and improvement opportunities for assigned programs.
- Partner with stakeholders to mitigate identified risks and implement associated actions.
- Support preparation of CMC clinical and commercial regulatory submissions.
- Collaborate with cross-functional partners to prepare for and support Health Authority inspections.
- In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
- Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
- Broad technical knowledge in AAV/Cell technology, aseptic processing, process & analytical development, manufacturing science & technology, etc.
- Ability to lead improvement projects and apply critical thinking and problem-solving skills to decision-making and operational priorities.
- Strong leadership and an innate ability to mentor, collaborate, and build relationships.
- Bachelor's degree in an engineering/Lifesciences field.
- Master's degree or relevant comparable background.
- Typically requires 10+ years of relevant industry experience in manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
- Minimum of 3 years leadership experience leading teams or directing allocation of resources.
