Johnson & Johnson is looking to solve the problem of ensuring product quality for patients by recruiting a Senior Manager Product Quality Integrator to develop and lead quality strategies for new products from early development through commercialization.
Requirements
- Minimum 5 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 basic knowledge of financial management, budgeting, and business case calculation.
- Project management experience.
- Excellent communication and organization skills required. Strong presentation, written and oral communication skills as well as the ability to meet due dates.
- Attention to detail and analytical / problem-solving skills.
- Business oriented, independent, and driven.
Responsibilities
- Ensures product quality for patients.
- Represents Global Quality on the CMC and Value Chain (VCT) Teams. Provides liaison between VCT and Analytical group.
- Represents Product Quality Management (PQM) in a leadership role in various multidisciplinary project teams, committees and special projects as assigned.
- Ensures Quality milestones and Quality stage gate deliverables are achieved. Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated HA questions on the filings.
- Assures product quality development through launch, understands the performance, and risk profile.
- Supports the manufacturing sites, represents the sites on CMC and VC teams.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Other
- Travel: approx. 10% of time based on specific business needs.
- Proficient in English.
- Minimum of Master / Bachelor´s degree in a scientific discipline.
- Experience in leading a global team is a plus.
- Demonstrated leadership in bringing products through development to launch is a plus.
