Director, Product Quality Integrator

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Job Function:
Quality Job Sub Function:
Multi-Family Quality Job Category:
Professional All Job Posting Locations:
Horsham, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for Director, Product Quality Integrator to join our Quality organization located in Horsham, PA. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

• Has end-to-end accountability for the quality strategy and quality aspects of new products from Early Development through commercialization for an assigned portfolio of products.
• Develops and leads the quality and regulatory strategies to support new platforms that are in- licensed or developed within the Janssen Supply Chain or other J&J operating companies.
• Develops and/or translates creative and innovative compliant approaches to introduce new products that are introduced right the first time and result in first-pass approval.
• Helps resolve issues and facilitates the timely advancement of new products to ensure 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.
• Serves as a consultant and mentor to colleagues and management

• Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable.
• Represents Global Quality on the CMC and Value Chain (VCT) Teams.
• Provides liaison between VCT and Analytical group.
• Serves as the single point of Global Quality contact for an assigned group of products with high complexity.
• Establishes and develops strong working relationships with key stakeholders (within JSC, R&D, and J&J) on a global basis.
• Represents PQM in a leadership role in various multidisciplinary project teams, committees and special projects as assigned.
• Provides oversight for the development and maintenance of specific programs and/or projects.
• Serves as champion for key projects.
• 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.
• Approves filings and questions for secondary filings.
• Support PAI audits for the product assigned.
• Accountable for readiness of stability protocols and reports for NPI process validation and the commitment protocol for primary filings.
• Liaises with Product data specialists or Product quality specialists to gather input on stability topics (e.g. draft stability protocols and reports).
• Collaborates with a Product Quality Specialist on regulatory questions and on preparation of regulatory PA inspections.
• Has line management responsibilities (if applicable) leading a group of Senior Managers or Managers.
• Is responsible for one or more products (with high complexity) directly and for other products (with lower complexity) through the direct reports.
• May also have responsibility for Product Quality Specialists, who are not assigned to a specific product and serve as a pooled resource across Directors’ teams.
• Director supports the reporting PQS and helps him or her prioritize tasks/queries.
• Mentors within Product Quality and Quality Integrator sub-team.
• Defines and oversees…