Senior Manager, Product Quality Integrator

Johnson & Johnson•Titusville, PA

20d•Hybrid

About The Position

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 As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics to be based in Malvern, PA; Horsham, PA; Spring House, PA; or Titusville, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Purpose: 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.

Requirements

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.
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 Malvern, PA; Titusville, NJ; or Horsham, PA; and may require up to 10% domestic and international travel as business demands.
Required Skills: Business Alignment, Collaborating, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

Nice To Haves

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

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.
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.

Benefits

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
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits