Senior Manager, Product Quality Management

Janssen Pharmaceutical, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Manager, Product Quality Management, Quality Integrator! The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Raritan, NJ; Horsham, PA or Chesterbrook, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more atwww.janssen.comand follow us @JanssenGlobal.Janssen Supply Group, LLCis part of the Janssen Pharmaceutical Companies.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Senior Manager, Product Quality, 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.

Key Responsibilities:

• Represents Global Quality Chemistry, Manufacturing, and Controls (CMC) and Value Chain Team (VCT). Serves as liaison between CMC team, Analytical Development and Product Quality Management. Serves as the single point of Global Quality contact. Drives communication with all Q&C stakeholders.
• Assures Quality milestones and Quality stage gate deliverables are achieved.
• Quality reviewer of health authority submissions (i.e., IND, 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 assigned.
• Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
• 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.
  • Assures patients get the right quality products.
  • 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.
  • API, RM, FP specifications approvals.
• 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 co- ordinate 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.

Qualifications

Education:

A minimum of a Bachelor’s or equivalent University degree is required with a major or concentration in one of the following: Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree preferred. A Master’s or advanced degree is desirable.

Required:

• A minimum of 8 years’ relevant work experience
• Experience in the pharmaceutical, biotechnology, or medical device industry
• In-depth knowledge in cGMP standards, policies and procedures
• Knowledge of Biotech and/or Sterile Pharma Manufacturing
• In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
• Relationship building, partnering and influencing in a matrix organization
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
• Understanding the business implications regarding quality positions and decisions
• Demonstrated experience in driving creative solutions and analytical skills
• Demonstrated ability to be a strong change facilitator to drive a team towards decisions in an environment with medium levels of ambiguity, complexity and risk
• Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time

Preferred:

• Experience in technology transfer, process development and/or process validation is preferred
• Consistent track record in leading multifunctional ‘virtual’ teams to success
• Experience in Product & Process Development
• Experience with Quality content of Regulatory filings: questions, and responses
• Experience with regulatory inspections and preparedness

Other:

• This position may require up to 10-25% domestic and international travel as business demands.
• Must be proficient in the English language (speak, read, write)

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.

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.

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.]

Primary Location
United States-Pennsylvania-Wayne-955/965 Chesterbrook Blvd
Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Ireland-Cork
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2206023908W