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:** 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 acrossAPI site(s),DP site(s), package and label as well as QC testing, stability testing andrelease across the various manufacturing sites. + The Product Quality Owner (PQO) establishesandmaintainssiteQualitycontacts and drives communication with all Q&C stakeholders . + The PQO assuresQualitymilestonesandQuality deliverables are achieved andapprovescontentofspec changes to ensure spec changes arealignedend-to-end.Assure multisite/global/highlevel product CAPAs andchangecontrols to ensure they are approved and closedappropriately. 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: + Assuresproductqualityover the lifecycle,understands the performance, and riskprofile,throughoutshelf-life + Ensurespatients get the right quality products. + Supports the manufacturing sites, represents the siteson VCM Team. + Supports QA communication/issueresolution with ExternalManufacturers 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 thePPQS in advance of Review Board and ExecutiveManagement Review. + Supports preparation of thecriticalityanalysisperschedule. + Ensurescomplaints are wellmanaged,issues are understood, and trends in Global Medical Safety (GMS) are understoodandaddressedasnecessary.Participate in productsafetymanagementteamstopresentProductQualityComplaintstrendsand topics. + Coordinatesand/or owner of complaints trend signal investigations. + Partners with QualityIntegratortocompleteTransfer of Ownership activities. + API, RM,FPspecificationschangeapprovals. Presents project updates to Quality Management for Quality alignment + Escalateissues when appropriate.Works with the crossfunctional/site teams to prepare,coordinate and lead quality Escalationmeetings,, followup onactions. ParticipatesandactivelyengagesonIMTs.Supportsfield/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/coordinatesdecisions and makes decisionsonbehalfof Global Quality including sites. + Gives inputtothedevelopmentof new strategies andimplementsanddeploysstrategies. + Aids in the creation of productportfolio guidelinesonthe control strategy for commercialproducts which will influence the life cyclemanagement strategy and the total quality cost duringcommercialproduction. + Provides Qualitystructure, direction and decision making to theteams(Quality and VCT) in situations of mediumrisk,uncertainty andambiguity. + 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.