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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.

Essential Job Duties and Responsibilities

• Hasend-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 thequality and regulatory strategies to support new platforms that are in- licensed or developed within the Janssen Supply Chain or other J&J operating companies.
• Developsand/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

Main Duties / AdditionalDuties / Sphere of Authority

PrincipalDuties:

• Compliance with theGMP, EHS and SOX requirements and guidelines, as applicable.
• RepresentsGlobal 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.
• RepresentsPQM 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.
• EnsuresQuality 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 stabilityprotocols 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 ProductQuality Specialist on regulatory questions and on preparation of regulatory PA inspections.
• Hasline 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 haveresponsibility 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 the necessary QA resource for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that ensures Quality throughout clinical, DS, DP, FF & device:

• Ensures product quality development through launch, understand 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.

• Ensures standard Global Quality new product introduction processes and norms are current, used across sites and facilitates communication throughout Global Quality.

• Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
• Supports preparation of the criticality analysis per schedule.
• Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
• Partners with Quality Owner to complete Transfer of Ownership activities.
• API, RM, FP specifications approvals.

• 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.
• Maintains the flow of communications between Global Quality and the CMC and VC Teams. Represents Product Quality at CMC Council. Drives communication with all Q&C stakeholders.
• Support agency audits for the product assigned.
• Presents project updates to QM for Global Quality alignment in advance of Stage Gate.

• Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.

Decisionmaking 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.
• Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
• Collaborates and support on the organization and transformation initiatives.
• Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
• Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of high risk, uncertainty and ambiguity.

Innovation/Creativity:

• Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.

Minimum Qualification

• A minimum of a Bachelor’s degree is required.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g MS Office, SAP
• Excellent analytical skill to identify gaps and root causes of issues, and think out of the box to develop a solution.
• Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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Required Skills:

Preferred Skills: