Senior Manager, Product Quality Integrator

Regulatory Jobs; Malvern (Chester County); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson's Janssen Pharmaceutical Companies seeks a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics, to own quality strategy from development through commercialization for large-molecule products. The role is located at multiple U.S.

sites, including Titusville, Horsham, Malvern, or Chesterbrook, PA, with international travel as needed. The position requires 8+ years in pharma/biotech, strong cGMP knowledge, and the ability to lead cross-functional teams.

Qualifications

• Bachelor’s degree in a technical/scientific field (pharma/biology/biotech/engineering)
• Minimum 8 years of experience in pharmaceutical or biotechnology
• Knowledge of cGMP standards, policies and procedures
• Ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
• Willingness to work across US/EMEA/APAC time zones; up to 10% travel
• Location options include Cork, Leiden, Beerse, Schaffhausen, Titusville, NJ; Horsham, PA; or Chesterbrook, PA

Responsibilities

• Represents Global Quality on CMC and Value Chain Teams; liaises between VCT and Analytical group
• Ensures Quality stage gate deliverables are achieved
• Quality reviewer/approver of health authority submissions and questions; supports audits
• Defines and oversees QA resources for global and local QA of assigned products
• Leads QA integration team from development through launch for large molecules
• Leads QA sub-team across clinical, DS, DP, FF & device; ensures quality through Launch and Grow
• Ensures standard Global Quality processes across sites; manages PPQS prep and criticality analyses
• Represents Global Quality on Value Chain Teams; aligns strategy with corporate/regulatory plans
• Presents project updates to Quality Management; escalates issues; engages IMTs; supports recalls

Skills

cGMP knowledge

Cross-functional work

Regulatory filings

Risk assessment

Communication & leadership

Education

Bachelor’s degree in a technical/scientific field

Master’s degree preferred

Job description

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for two Senior Manager, Product Quality Integrators! This position can be located in Malvern, Springhouse, Horsham, PA and Titusville, NJ.

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for aSenior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position will be based at US sites

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 at www.janssen.com and follow us @JanssenGlobal.

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

Position Summary

The Senior 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 in Launch and Grow 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 VCT and Analytical group. Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality 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.
• 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:
  • Ensures 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 patients get the right quality products
• Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
  • Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
  • Supports preparation of the criticality analysis per schedule.
  • 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.

  Qualifications

  Education:

  A 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

  Required

  • A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry
  • Knowledge in cGMP standards, policies and procedures
  • Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
  • Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
  • 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

  Preferred

  • A Master’s degree or other advanced degree
  • Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing
  • Experience in technology transfer, process development and/or process validation
  • In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies
  • Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities
  • Experience in API and Drug Product stability

  Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

  Required Skills:

  Preferred Skills:

  The anticipated base pay range for this position is :

  $122,000.00 - $212,750.00

  Additional Description for Pay Transparency:

  Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  Vacation –120 hours per calendar year
  Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  Holiday pay, including Floating Holidays –13 days per calendar year
  Work, Personal and Family Time - up to 40 hours per calendar year
  Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  Caregiver Leave – 80 hours in a 52-week rolling period10 days
  Volunteer Leave – 32 hours per calendar year
  Military Spouse Time-Off – 80 hours per calendar year