Manager 2 Pharma Quality Systems Capa

Janssen Supply Group L.L.C. is recruiting for a Sr. Manager, Quality Systems CAPA, This position has a primary location of Titusville, NJ. It can also be based in Bern, Switzerland; Schaffhausen, Switzerland; Beerse, Belgium; Latina, Italy; Cork Ireland; Leiden Netherlands; Raritan, NJ or Gurabo, Puerto Rico. Outside of the United States, other consideration maybe given to work locations out of any J&J Janssen Supply Chain site globally.

Join us to innovate and craft an enhanced framework, process and supporting tools to simplify and improve the investigation and CAPA landscape across the Janssen Supply Chain Enable implementation of new ways of working and drive systemic improvements in the way we investigate issues and implement sustainable corrective and preventive actions

This position will initially support Project Sherlock, which is driving a Quality Improvement Plan to design and implement comprehensive enhancements to the NC/CAPA system across JSC. As the future-state framework is implemented, this role will transition to a sustainability model and will lead ongoing support to select sites within JSC. Main responsibilities will include:

- Leading global improvements to process and platform across Janssen, driving excellence in processes and execution.
- Working with site NC/CAPA business process owners (BPOs) to establish and standardize NC/CAPA processes in support of all JSC sites and functions. Establishes and reports metrics that are indicative of the process health and overall compliance.
- Acting as core team member on the Segment NC/CAPA Council.

**Key Responsibilities**:
**Governance and tracking**:

- Establish and own an efficient and effective governance program for review of NC/CAPA process, execution, status & metrics globally. The overall health of process execution and compliance to standards and requirements is in scope.
- Chair the cross-site CRB process for JSC. Liaise with site CRB process owners to align to metrics and champion accuracy and consistency of tracking to allow for a global view compliance. Participate in site level CRBs as an ad hoc member for sites in scope.
- Support user training and certification. Monitor the health and quality of the overall system. Supervise the program for training/certification of users and ensure that sufficient resources are identified to coach and mentor users at the site level. Deliver education and interactive training to deliver consistent compliant records including Failure Investigation, CAPA Review Boards, and CAPA content.

**Metrics**:

- Provide key risk indicators to the relevant Business Process and QS Management Review venues. Ensure that actions are taken by responsible functions for lapses in compliance thresholds.
- Engage site/function Subject Matter Experts (SME)/Coaches to improve and align processes locally. Use appropriate project management tools to manage and track activities.
- Collaborate with JJT and other functions on enhancement requests for configuration of systems (e.g., Track Wise) to enable process improvements.
- Other duties as assigned to advance overall compliance and execution of the system.

**Qualifications** Qualifications**

**Education**:

- A bachelor’s degree and at least 8 years of related experience in the pharmaceutical and/or medical device industry is required.

**Experience and Skills**:
**Required**:

- Proven expert level of understanding and thought leadership of worldwide regulations, industry expectations, and trends for nonconformance, root cause analysis, corrective and prevent actions (end-to-end CAPA process).

**Preferred**:

- Certification or qualification to a company, industry or regulatory-sponsored Investigation or CAPA Skills program is desired.
- Prior experience with Health Authority inspections or interactions is desired**.**:

- Experience with digital tools, such as visualization/reporting tools, artificial intelligence, or automation solutions, is preferred
- Ability to effectively navigate in a diverse organization, working across a global organization to drive alignment
- High degree of interdependent partnering, influencing, and collaboration required
- Ability to lead multiple projects and priorities to remain effective and focused on business critical objectives
- Strong collaboration and communication skills required

**Other**:

- Less than 5% travel (domestic and/or international) may be required for this role.

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.

**Primary Location**
United States-New Jersey-Titusville-1125 Trenton Harbourton Road

**Other Locations**
Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Netherlands-South Holland-Leid