Sr. Manager, Product Quality Integrator

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Janssen Pharmaceutical a member of Johnson & Johnsons Family of Companies is recruiting for a Senior Manager Product Quality Integrator Launch & Grow Biotherapeutics.

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 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.

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.

• 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.

Qualifications

• A minimum of a bachelors 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 can be located in Europe: Ireland Netherlands Belgium Switzerland and may require up to 10% domestic and international travel as business demands

Preferred

• A Masters 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

At Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds 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 depending on location and subject to local legislation candidates offered employment may be required to show proof of COVID-19 vaccination or in certain countries 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. If you are invited to interview for the position your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.

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