Join to apply for the Sr Mgr Product Quality Owner role at Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
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
* Ensure compliance with GMP, EHS, and SOX requirements and guidelines, as applicable. Serve as the single point of contact for Product Quality Management for assigned Value Optimizer and Late Stage marketed Biotherapeutic and Synthetic products with medium to high complexity.
* Responsible for end-to-end Quality oversight for assigned products across API site(s), DP site(s), packaging, labeling, QC testing, stability testing, and release across manufacturing sites.
* Establish and maintain site Quality contacts and drive communication with all Q&C stakeholders.
* Ensure Quality milestones and deliverables are achieved; approve content of spec changes; oversee multisite/global/high-level product CAPAs and change controls.
* Collaborate with IM Supply Chain Quality, External Quality, and commercial quality teams to troubleshoot and support business needs.
* Represent IM Product Quality Management on the Value Chain Management Teams (VCM) and maintain communication flow.
* Support business continuity including Product Strategy Roadmaps and BCP projects.
* Work with MSAT Synthetic and Biotherapeutic partners for troubleshooting and support via forums such as TRCs, COPs, NSC.
* Review Proactive Product Quality Scans (PPQS), prepare quality sections of Product Strategy, and participate in VCM meetings.
* Manage stability activities, including change management studies, regulatory questions, and shelf life/retest period adjustments.
* Drive continuous improvement and harmonization of proactive product risk management processes.
* Connect across quality organizations to ensure product quality throughout the lifecycle, supporting API, DP, Fill Finish, and device quality.
* Ensure standard global quality processes are used across sites, facilitate communication, and manage complaint trends and investigations.
* Prepare for and support regulatory filings, agency audits, and health authority requests.
* Demonstrate knowledge of new product launches, supply network planning, and supplier management.
Decision Making And Problem Solving
* Apply risk assessment strategies; define strategies and translate into actionable plans.
* Make decisions on behalf of Global Quality and support strategic development.
* Contribute to product portfolio guidelines and lifecycle management strategies.
* Provide leadership and decision-making support in situations of medium risk and ambiguity.
Leadership & Behavioral Competencies
* Experience leading global teams and influencing in a matrix organization.
* Strong communication, organization, negotiation, and problem-solving skills.
* Business-oriented, independent, and driven; open to diverse points of view; innovative and growth-focused.
Education And Experience
* Minimum 7 years in quality, compliance, or regulatory affairs within a regulated industry.
* Master/Bachelor’s in a scientific discipline with strong technical capabilities.
* Experience across multiple quality disciplines including manufacturing, analytical testing, and distribution.
* Knowledge of financial management, budgeting, and business case calculations.
* Fluent in English.
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