Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA or Wayne, PA.
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 Integrator, Launch and Grow Biotherapeutics has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization for an assigned group of large molecules (biological) products.
Main responsibilities include but are not limited to:
Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between CMC team, Analytical Development and Product Quality Management. Serves as the single point of Global Quality contact.
Assures Quality stage gate deliverables are achieved.
Quality reviewer 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.
Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:
Assures product quality development through Launch and Grow stage.
Supports the sites, represents the sites on CMC and VC teams.
Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
Ensures standard Global Quality processes (new product introduction processes, risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality.
Manages preparation of the iPPQS and 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 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 PQ VO&LS to complete Transfer of Ownership activities.
Represents Global Quality on the Value Chain Teams (VCT).
Maintains the flow of communications between Global Quality and VCT teams.
Brings Quality issues to the VCT and assists with prioritization of projects and with key product decisions.
Supports the business continuity process including VCT strategy and BCP projects.
Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
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.
Drives 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 new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.
Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.
A minimum of a Bachelor’s degree (or University equivalent) is required with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration
A Master’s degree or advanced is desirable (pharmaceutical, chemical background, biological necessary or a similar degree concentration) is preferred
A minimum of 5 years’ experience in the pharmaceutical, or biotechnology industry is required
Knowledge in cGMP standards, policies and procedures is required
Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering is required
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans is required
Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing is preferred
Experience in technology transfer, process development and/or process validation is preferred
In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies is preferred
Experience with developing and responding to quality content of regulatory filings, inspections and preparedness activities is preferred
Experience in API and Drug Product stability is a plus
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required
This position will be located in Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA or Chesterbrook, PA; and may require up to 10% domestic and international travel as business demands
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Wayne- Other Locations
Switzerland-Schaffhausen-Schaffhausen, Netherlands-South Holland-Leiden, United States-Pennsylvania-Horsham, Belgium-Antwerp-Beerse, Ireland-Cork-Cork, United States-New Jersey-Titusville Organization
JANSSEN SUPPLY GROUP, LLC (6046) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies