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Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Cork, Cork, Ireland, Gurabo, Puerto Rico, United States (inactive), Horsham, Pennsylvania, United States of America, Latina, Italy, Leiden, Netherlands, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Schaffhausen, Switzerland

Job Description:

J& J is recruiting a Senior Manager, Product Quality Owner within the Quality department, and reporting to the Director PQM.

Principal Duties:

Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable. Serves as the single point of contact for Product Quality Management for an assigned group of Value Optimizer and Late Stage marketed Biotherapeutic and Synthetic products with medium to high complexity.

• Responsible for ensuring end-to-end Quality for assigned Biotherapeutic and Synthetic products across API site(s), DP site(s), package and label as well as QC testing, stability testing and release across the various manufacturing sites.
• The Product Quality Owner (PQO) establishes and maintains site Quality contacts and drives communication with all Q& C stakeholders .
• The PQO assures Quality milestones and Quality deliverables are achieved and approves content of spec changes to ensure spec changes arealigned end-to-end. Assure multisite/global/high level product CAPAs and change controls to ensure they are approved and closed appropriately.

The PQO collaborates closely with IM Supply Chain Quality, External Quality and commercial quality across Value Optimizer and Late Stage marketed products to provide trouble shooting and business support.

Represents Innovative Medicine Product Quality Management on the Value Chain Management Teams (VCM). Maintains the flow of communications between Quality functions and VCM teams. Brings Quality issues to the Value Chain Managers and assists with prioritization of projects and with key product decisions.

Supports the business continuity including Product Strategy Roadmaps and BCP projects.

The PQO collaborates closely with MSAT Synthetic and Biotherapeutic partners across Value Optimizer and Late Stage marketed products to provide trouble shooting and business support tactically and strategically through various forums such as TRCs (Tech Review Committees), COPs (Community of Practices), NSC (Network Sourcing Committee) etc.

The PQO collaborates closely with MSAT Synthetic and Biotherapeutic partners across Value Optimizer and Late Stage marketed products to provide trouble shooting and business support.

Reviews Proactive Product Quality Scans (PPQS) with the VCM and assures appropriate mitigating actions are defined there. Prepares quality sections of Product Strategy and End-to-end Value Stream Mapping. Participates in the VCM meetings on PSR and VCM finalization and project prioritization. Aligns and interfaces the JSC Product Strategy with other existing strategies: J& J corporate strategies, commercial strategies, R& D strategies, regulatory strategies, etc.

The PQO Represents Innovative Medicine on the Divestment and delisting strategy deployment and support activities

Accountable for all stability related activities of commercialized products including change management study management. Liaises with Product Quality specialists to gather input on stability topics (e.g. stability protocols and reports).

Collaborates with a Product Quality Specialist on regulatory questions related to stability and on preparation of regulatory PA inspections regarding stability topics.

Manages changes of shelf life / retest period and storage instruction.

The PQO is responsible for providing quality oversight & drives continuous, harmonization and standardization of proactive product risk management processes

Connect across quality organizations to assure Quality throughout, API, DP, Fill Finish and device:

• Assures product quality over the life cycle, understands the performance, and risk profile, throughout shelf-life
• Ensures patients get the right quality products.
• Supports the manufacturing sites, represents the sites on VCM Team.
• Supports QA communication/issue resolution with External Manufacturers and
• Business Partners, as applicable.

Ensures standard Global Quality processes (risk assessments, technology transfers) are 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 trends in Global Medical Safety (GMS) are understood and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
• Coordinates and/or owner of complaints trend signal investigations.
• Partners with Quality Integrator to complete Transfer of Ownership activities.
• API, RM, FP specifications change approvals.

Presents project updates to Quality Management for Quality alignment

• Escalate issues when appropriate. Works with the cross functional/site teams to prepare, coordinate and lead quality Escalation meetings, , follow up on actions. Participates and actively engages on IMTs. Supports field/recalls as needed.

Review/approval/support regulatory filings and answering questions from the agency during filing review.

Support agency audits and health authority requests for the product assigned.

• Demonstrate basic knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
• Gives inputs and provide guidance on production quality and packaging application related subjects.

Decision making and Problem Solving:

• Strong analytical thinking, decision-making and leadership skills.
• Able to apply appropriate risk assessment strategies to manage business & compliance priorities
• Ability to define strategies and translate them into actionable items and an action plans.
• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• 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 commercial products which will influence the life cycle management strategy and the total quality cost during commercial production.
• Provides Quality structure, direction and decision making to the teams (Quality and VCT) in situations of medium risk, uncertainty and ambiguity.
• Collaborate and support on the organization and transformation initiatives.

Leadership & Behavioral Competencies

• Experience in a successful leadership role in building, inspiring and managing a global team and influencing stakeholders across a matrixed organization structure.
• Well-developed leadership skills and the ability to influence others in a matrix environment.
• Excellent communication and organization skills required. Solid presentation, written and oral communication skills as well as the ability to meet deadlines. Strong attention to detail and analytical / problem-solving skills.
• Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners
• Business oriented, independent and driven.
• Seeks, listens to, and incorporates diverse points of view (Connect)
• Courageously tries new things, test and learns from mistakes. (Shape)
• Develops self and others to reach their goals (Grow)
• Engages in open and honest conversations (Grow)

Education and Experience:

• Minimum 7 years of experience in quality, compliance or regulatory affairs in a regulated industry.
• Minimum of Master / Bachelor´s degree in a scientific discipline, but essential that the individual has excellent scientific & technical capabilities based on combination of qualification and experience.
• Experience in more than one quality related disciplines is essential including, but not limited to, manufacturing and packaging operations, analytical and micro testing and commercial distribution, basic knowledge of new product introduction.
• Demonstrate medium knowledge of financial management, budgeting and business case calculation.
• Fluent in English.