Sr Mgr Product Quality Integrator

ppJohnson Johnson Innovative Medicine (JJ IM) is recruiting for a Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics. The position will be based at our European sites /ppThe Senior Manager, Product Quality Integrator, Quality Asset Management Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow to Late Stage for an assigned group of Biotherapeutic (large molecule) products. /ph3Main responsibilities include but are not limited to: /h3ulliRepresents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact. /liliEnsures Quality stage gate deliverables are achieved. /liliQuality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned. /liliDefines and oversees the necessary QA resource for global and local QA of his or her assigned products. /liliLeads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, device and packaging: development through launch and commercial lifecycle. /liliLeads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, device and packaging; /liliEnsures product quality development through Product Lifecycle. /liliSupports the sites, represents the sites on CMC and VC teams. /liliSupports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable. /liliEnsures standard Global Quality processes (PPQS, CA, PRA, Complaints, Escalations) are used across sites and facilitates communication throughout Global Quality. /liliPresents project updates to Quality Asset Management for Global Quality alignment. /liliDrives Decision making and Problem Solving. /li /ulh3Qualifications Required /h3ulliA minimum of a bachelor’s degree (or University equivalent) with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration /liliA minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry /liliKnowledge in cGMP standards, policies and procedures /liliDemonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering /liliAbility to quickly assimilate new technologies, perform risk assessment and develop action plans /liliFlexible hours to accommodate US, EMEA and APAC work schedules when necessary, balancing work and personal time is required /liliThis position will be located in Europe (Cork Ireland, Leiden Netherlands, other) and may require up to 10% domestic and international travel as business demands /li /ulh3Preferred /h3ulliA Master’s degree or other advanced degree /liliKnowledge of biotech, biotherapeutics and/or sterile pharmaceutical manufacturing /liliExperience in technology transfer, process development and/or process validation /liliIn-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies /liliExperience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities /li /ulh3Preferred Skills: /h3ulliBusiness Alignment /liliCollaboration /liliCompliance Management /liliFact-Based Decision Making /liliGood Manufacturing Practices (GMP) /liliISO 9001 /liliMentorship /liliOrganizing /liliQuality Auditing /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRegulatory Environment /liliStandard Operating Procedure (SOP) /liliTactical Thinking /liliTechnical Credibility /li /ul /p #J-18808-Ljbffr