Sr Manager Product Quality Integrator

Job content

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; Horsham, PA or Chesterbrook, 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 Senior Manager, Product Quality, Launch and Grow Biotherapeutics has end-to-ended 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 partners.
• Assures Quality achievements and Quality stage gate deliverables are achieved.
• Quality reviewer of health authority (HA) 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.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical development:
• Assures product quality development through Launch and Grow stage.
• Supports the sites, represents the sites on CMC and Value Chain Teams (VCT).
• 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.
• Leads 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 handled, issues are understood, and addressed as vital. 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.
• 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.
• Presents project updates to quality management for Global Quality alignment.
• Advance issues when appropriate. Works with the cross functional/site teams to co- ordinate and hold Critical issue meetings, minutes archival, follow up on actions.
• Participates and actively engages on Issue Management Teams (IMTs). Supports field actions/recalls as needed.
• Drives Decision making and Problem Solving:
• Drives/coordinates decisions on behalf of Global Quality.
• Gives input to the development and deployment of new 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 and time to market.
• Provides Quality structure, direction and decision making to the teams (Quality, CMC and VCT) 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.
  

Education

Qualifications

• A minimum of a bachelor’s degree is required with a major or concentration in one of the following: Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree concentration.
• A Master’s degree or advanced (pharmaceutical, chemical background, biological vital or a similar degree concentration) is preferred
  

Required Skills:

• A minimum of 8 years’ experience in a highly regulated industry is required
• Experience in the pharmaceutical, biotechnology, or medical device industry is required
• In-depth knowledge in cGMP standards, policies and procedures is required
• Knowledge of Biotech and/or Sterile Pharmaceutical Manufacturing is required
• In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies is required
• Proven ability to work across organizational boundaries and within a matrixed organization through communicating, influencing, negotiation and partnering is required
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans is required.
• Proven experience in driving creative solutions and analytical skills are required.
• 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 is required.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules when vital, balancing work and personal time is required
  

Preferred Skills:

• Experience in API and Drug Product stability is a plus
• Experience with regulatory inspections and preparedness is preferred
• Experience with Quality content of Regulatory filings: questions, and responses is preferred
• Experience in tech transfer, product, or process development and/or process validation is preferred
• Proven track record in leading multifunctional ‘virtual’ teams to success is a plus
  

Other:

• This position may require up to 10-15% domestic and international travel as business demands.
  

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 ground breaking 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

Netherlands-South Holland-Leiden, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization

JANSSEN SUPPLY GROUP, LLC (6046)

Job Function

Quality

Requisition ID

2206062432W