Product Quality Integrator

Il y a 4 mois

Antwerpen, Belgique Johnson & Johnson Temps plein

Johnson & Johnson is recruiting for a **Product Quality Integrator (PQI) Director **.

The PQI director 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.

**Key Responsibilities**:

- Ensures product quality for patients.
- 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 (within SC, TDS, and J&J) on a global basis. Drives communication within Q&C.
- Represents Product Quality Management (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.
- 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. Supports PAI audits for the product assigned.
- Has line management responsibilities, leading a group of Senior Managers or Managers. Is responsible for one or more products directly and for other products through the team.
- Mentors within Product Quality and Quality Integrator sub-team.
- Defines and coordinates the necessary Quality resources.
- Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device:

- Assures product quality development through launch, understands the performance, and risk profile.
- Supports the 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 (J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.).
- 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. Makes a positive contribution by making suggestions for improvement.
- Demonstrate high knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
- Presents project updates to Quality leadership for Global Q&C alignment in advance of Stage Gates and commercial sourcing decisions.
- Escalates issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, participates and/or leads Issue Management teams. 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 (Quality, CMC and VC Team) in situations of high risk, uncertainty and ambiguity.
- Is expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs, thus providing the best total value to the company.

**Qualifications**:
**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, and it is essential that the individual has excellent scientific & technical capabilities based on a combination of 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

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