SR Manager Product Quality Integrator (2 openings)

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; Malvern (Chester County); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson seeks a Senior Manager, Product Quality Integrator, Launch and Grow Biotherapeutics to own quality strategy from Early Development through commercialization for large molecule products. You will lead global quality activities, coordinate with CMC and Value Chain teams, and ensure readiness for regulatory submissions.

The role requires 8+ years in pharma/biotech, strong knowledge of cGMP, and flexibility to travel.

Qualifications

• A minimum of 8 years’ experience in the pharmaceutical or biotechnology industry.
• Knowledge in cGMP standards, policies and procedures.
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans.
• Flexible hours to accommodate US, EMEA and ASPAC work schedules.
• Location: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA; or Chesterbrook, PA; up to 10% travel.

Responsibilities

• Represent Global Quality on the CMC and VCT teams.
• Liaise between VCT and Analytical group.
• Be the single Global Quality contact for assigned products.
• Ensure Quality stage gate deliverables are achieved.
• Review quality content for regulatory filings (IND, IMPD, BLA, NDA, MAA).
• Lead QA resources for global and local QA of assigned products.
• Oversee QA during development through Launch and Grow stages.
• Support field/recalls as needed.
• Drive quality decisions with cross-functional teams.

Skills

Cross-functional collaboration

Risk assessment

Action planning

Education

Bachelor’s degree in Pharmacy/Biology/Biochemistry/Biotechnology/Engineering

Master’s degree preferred

Job description

Company Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Details

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

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

• 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.
• 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 Product Quality Owner (PQO) Value Optimize & Late Stage 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.
• Present 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.

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.

Salary & Benefits

• 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.

EEO Statement

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.