Director Product Quality Integrator

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Overview

Johnson and Johnson Innovative Medicine is recruiting globally for a Director Product Quality Integrator (PQI), in the Product Quality Management Synthetics organization and reporting to the Sr Director PQ Launch&Grow.

Responsibilities

• The Director Product Quality Integrator 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 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. Serves as a consultant and mentor to colleagues and management.
• Ensures product quality for patients and 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. Establishes and develops strong working relationships with business partners on a global basis. Drives communication within Quality & Compliance.
• Represents Product Quality Management (PQM) in a leadership role in multidisciplinary project teams, committees and special projects. Provides oversight for the development and maintenance of specific programs and/or projects.
• Ensures Quality milestones and Quality stage gate deliverables are achieved. Acts as quality reviewer/approver of health authority submissions (e.g., BLA, NDA, MAA) and associated HA questions on filings. Approves filings and questions for secondary filings. Supports PAI audits for the product assigned.
• Has line management responsibilities, leading a group of Senior Managers or Managers. Responsible for one or more products directly and for other products through the team.
• Mentors within Product Quality and the Quality Integrator sub-team.
• Defines and coordinates the necessary Quality resources. Ensures 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.
• Participates in Product Strategy Reviews, in alignment with the Supply Chain Product Strategy with other existing strategies (corporate, commercial, R&D, regulatory, etc.).
• Ensures 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. Contributes ideas for improvement.
• Demonstrates knowledge of new product launch (new filing, launches, regulatory impact, basics of clinical trials management) and supply network planning and supplier management. Provides inputs and guidance on production quality and packaging applications.
• Presents project updates to Quality leadership for Global Q&C alignment in advance of Stage Gates and commercial sourcing decisions. Escalates issues when appropriate and coordinates cross-functional escalation meetings. Supports field actions/recalls as needed.

Decision making and Problem Solving

• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• Identifies and provides balanced management of quality and compliance risks with business needs.
• Collaborates and supports the organization on transformation initiatives.
• Provides Quality structure, direction and decision making to the teams in situations of high risk, uncertainty and ambiguity.
• Brings creative solutions to define a compliant quality strategy with flexibility for business needs, delivering the best total value to the company.

Qualifications

• 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, with excellent scientific & technical capabilities based on qualification and experience.
• Demonstrate medium knowledge of financial management, budgeting, and business case calculation.

Experience and Skills

• 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; strong presentation, written and verbal communication; ability to meet due dates; attention to detail; analytical/problem-solving skills.
• Business oriented, independent, and driven.

Other

• Proficient in English.
• Travel: approximately 10% of time based on specific business needs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Italy, Belgium, Switzerland, Ireland, India - Requisition Number: R- ; United States - Requisition Number: R- . Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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