Manager Product Quality Owner

工作内容

Janssen Pharmaceutical, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Manager Product Quality Owner. The position should be based on the following sites: Raritan, NJ, Beerse, Belgium, Latina, Italy, Leiden, The Netherlands, Cork, Ireland, Malvern, Springhouse, Chesterbrook, USA, Schaffhausen in Switzerland, Guaynabo, Puerto Rico.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.The Manager Product Quality Owner has end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products.Key ResponsibilitiesCompliance with the GMP, EHS and SOX requirements and guidelines, as applicable. Serves as the single point of Global Quality contact for an assigned group of marketed products with low to medium complexity. Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release. The Quality Owner (QO) knows the product history and understands the processes across the various manufacturing sites. The QO establishes and maintains site Quality contacts and drives communication with all Q&C stakeholders. Assures Quality milestones and Quality deliverables are achieved and approves content of spec changes to ensure spec changes are aligned end-to-end. Supports multisite/global/high level product CAPAs and change controls to ensure they are approved and closed appropriately.Represents Global Quality on the Value Stream Teams (VST). Maintains the flow of communications between Global Quality and VST teams. Brings Quality issues to the VST and assists with prioritization of projects and with key product decisions. Supports the business continuity process including VST strategy and BCP projects. Reviews Proactive Product Quality Scans with the VST and supports appropriate mitigating actions. Prepares quality sections of Product Strategy and End-to-end Value Stream Mapping. Participates in the F2F VST meetings on PSR and VSM 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.Accountable for all stability related activities of commercialized products including change management study management. 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 Product Quality Specialist on regulatory questions related to stability and on preparation of regulatory PA inspections regarding stability topics.Defines and oversees the necessary QA resources for global and local Q of his or her assigned products.

• Leads a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish & 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 sites, represents the sites on VS 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 QM for Global Quality alignment
• Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions. Participates and actively engages on IMTs. Supports field/recalls as needed.
• 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:

• 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 VST) in situations of medium risk, uncertainty and ambiguity.
• Collaborate and support on the organization and transformation initiatives.

Innovation/Creativity:

• 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.

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.
• Business oriented, independent and driven.

Qualifications

• Minimum 5 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 basic knowledge of financial management, budgeting and business case calculation.
• Fluent in English.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary LocationUnited States-New Jersey-Raritan-1000 US HIghway 202Other LocationsEurope/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-Pennsylvania-Chesterbrook, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland-Schaffhausen, North America-United States, Europe/Middle East/Africa-Ireland-Cork, United States-Puerto Rico-Guaynabo, Europe/Middle East/Africa-Italy-LatinaOrganizationJANSSEN SUPPLY GROUP, LLC (6046)Job FunctionQualityRequisition ID2206082216W