As part of the Global Products Quality Management organization, the Development Quality Lead is responsible for strategic quality management across Pharma and/or Biotech Sciences groups in product and process development activities according to ICH guidelines. This role involves collaborating with various functions involved in CMC and GMP strategic activities, ensuring the development of quality products, compliance to regulatory requirements, and effective coordination with other global QA functions.
A) Early Development Stages up to Proof of Concept (PoC):
- Provide guidance on QbD guidelines, cGMP regulations, and ICH guidelines.
- Ensure consistency of CMC QA activities across different environments and teams.
- Review and approve documentation for CMC projects (process descriptions, specifications, etc.).
- Lead QA participation in cross-functional partnerships to identify and resolve compliance and quality issues.
- Support CMC regulatory submissions and address operational deficiencies.
B) Late-Stage Development to Commercial Launch:
- Oversee CMC strategy documentation and ensure consistency in QA activities.
- Coordinate QA review and approval of late-stage development documents.
- Transfer product and process control strategy documents to Global Quality Lead.
- Manage CMC regulatory filing activities for product registration.
- Ensure compliance with regulations and support audit preparations.
Education & Qualification:
- Bachelor's Degree in Chemistry, Biology, Pharmacy, or related field.
- Certified auditor is an asset.
- Minimum 7 years of experience in a pharmaceutical regulated environment.
- Strong knowledge of QA and technical requirements in (Bio)Pharmaceutical development.
- Familiarity with regulatory requirements and ICH guidelines.
- Experience in partnering with Development stakeholders and coordinating QA functions.
- Excellent communication, teamwork, and project management skills.
- Strong analytical and organizational abilities.
- Fluent in English, other languages are an asset.
- Ability to lead, influence, and drive continuous improvement.
- Thorough understanding of cGMP and regulatory requirements.
- Fact-based decision-maker and creative problem solver.
- Skilled in presentations and cross-functional coordination.
- Strong compliance and quality oversight experience.