Johnson and Johnson Innovative Medicine is looking for a Director Product Quality Integrator to ensure end-to-end quality strategy and execution for new products from early development through commercialization, aiming for timely launches and patient safety.
Requirements
- Minimum 10 years of experience in quality, compliance or a scientific discipline in the pharmaceutical industry.
- Minimum of Master / Bachelor´s degree in a scientific discipline, and it is essential that the individual has excellent scientific & technical capabilities based on a combination of qualification and experience.
- Demonstrate high knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
- Gives inputs and provides guidance on production quality and packaging application related subjects.
- Ensures that Global Quality processes are followed, maintained and communicated, during development and across sites (e.g. PPQS, criticality analysis, complaints).
- Remains current in knowledge, skills and industry trends.
- Trains on new regulations, guidelines, procedures and processes.
Responsibilities
- Develops and leads the quality strategies to support new platforms that are in- licensed or developed within the J&J Supply Chain or other J&J operating companies.
- Develops and/or translates creative, innovative and compliant approaches to introduce new products, right-first-time and resulting in first-pass approval.
- Helps resolve issues and facilitates timely advancement of new products to ensure that they are filed and launched on time.
- Serves as the global resource to the entire Quality Organization to provide guidance, training, and consultation on new product development.
- Ensures product quality for patients.
- Represents Global Quality on the CMC and Value Chain (VCT) Teams.
- Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated HA questions on the filings.
Other
- Has line management responsibilities, leading a group of Senior Managers or Managers.
- Mentors within Product Quality and Quality Integrator sub-team.
- Establishes and develops strong working relationships with business partners (within SC, TDS, and J&J) on a global basis.
- Experience in a successful leadership role in building, inspiring and managing a global team and influencing across a matrix organization structure.
- Excellent communication and organization skills required.
