Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Quality Assurance to be based in Titusville, New Jersey. This role supports both the Raritan, NJ and Titusville, NJ Stability Lab locations, therefore routine travel between both sites is required.
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. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
The Quality Assurance Manager manages the stability site efforts to remain compliant with corporate and regulatory requirements. Establishes inspection readiness programs and ensures that site(s) quality systems supporting the facility maintain a state of inspection readiness. The QA Manager is responsible for ensuring that all planned and unplanned quality & compliance issues are addressed. Maintains quality oversight of the US Stability Laboratories. This role is a direct people leader who will manage direct reports.
Drives continuous improvement to create an agile QA organization. Assists to ensure site(s) are in full compliance with regulatory, industry, J&J and JSC requirements and standards. Plans, coordinates, leads and/or facilitates internal and external audits and provides support during regulatory visits.
This position is responsible for carrying out managerial responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.
Responsible for the efficient and effective functioning of the Stability Operations Quality Assurance department including the planning, coordination and direct supervision of activities being conducted by Quality Assurance Specialists.
Provides Quality review and guidance associated with investigations, change controls, protocols, reports, area releases, project planning and site procedures.
Maintains a high level of quality awareness and knowledge for Stability Operations, with understanding of the technical content of the reports, investigations, CAPAs that are documented by the group and escalates significant issues to the Site Quality Head.
Provides Quality/Compliance guidance and recommendations to site and QA personnel.
Serves as subject matter expert within Stability Operations.
Quality & Compliance:
- Manages quality metrics and drives improvements as needed
- Manages inspection readiness system and activities for the site, ensuring the sites are always in an inspection ready state
- Plans, coordinates, leads and/facilitates internal and external audits and provides leading role support during Health authority inspections. Responsible for response efforts for health authority inspections.
- Manages and trains QA Analysts on use of Quality Systems: Event and CAPA Management System, Document Management System, Learning Management System, Change Control System & new technologies
- Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented. Drives continuous improvement in Root Cause Investigation Process.
- Oversees Internal Audit Program, audit schedule development, and program improvement efforts and participates in or leads audits as required
- May participate in change controls, investigations, and corrective actions as owner, assessor or approver
- May approve (or develop) cGMP training materials/plans for functional areas within JSC Stab Ops
- May review and approve validation protocols and reports, equipment/facility change requests, calibration documentation
- Draft, edit and approve department procedures as needed and ensure document hierarchy is maintained in a logical state
- Carries out all duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, DEA, and OSHA and ensures that organization is equipped to do so
- Complies with all company and site policies standards and procedures
- Monitors/tracks changes in regulatory environment (e.g., compendia, regulations/directives, guidance documents, global standards) and assures impact of the changes to Stability Operations are assessed by appropriate SME and corrective actions implemented, as needed
- Manages timeliness of local investigations, Corrective Actions, Change Controls (e.g., tracks open records and assures closure)
- Understands stability operations, working independently on complex issue and supporting the organization to remediate and resolve difficult issues
- Escalates issues to quality management in timely manner and works with management to address and remediate issues
- Responsible for training new employees and providing mentorship, coaching, and support as needed
- A people leader who will train, develop, coach and mentor employees from a functional perspective as well as career development perspective
- Lead recruitment and make hiring decisions for open QA positions across Stability Operations
- Manage performance of the QA staff and take disciplinary action, where required
- Establish performance objectives and development goals for employees
- Coordinate the schedules of resources to ensure efficient coverage for all operational needs, where required
- Fosters a CREDO decision making process throughout the organization.
Projects / Meetings
- Facilitates or participates in any and all required meetings related to quality
- Responsible for Quality Site Management Review (SMR) and associated activities
- Support Lean initiatives as applicable and assist in driving Quality, Compliance and Lean thinking throughout Stability Operations
- Make decisions as a QA representative at cross-functional meetings and Quality Leadership meetings
- Connect with the QA Global Organization, being the main point of contact for the US Stability Organization and ensuring best practices are leveraged and implemented
- Participate in Industry and trade association groups (ICH, USP, etc.)
- A bachelors degree required. Degree concentration in a scientific, engineering or related area is preferred. Advanced degree (MBA, MS or PhD) preferred.
- Minimum of 8 years experience working in a regulated quality environment with a minimum of 3 years experience directly leading people required.
- Strong leadership and change management skills required.
- Expert knowledge and understanding of compendia (USP, EP, JP, etc.), global regulations, and current Good Manufacturing Practices (cGMP) pertaining to commercial pharmaceutical stability laboratory operations required.
- Advanced knowledge of Quality Lab Systems for investigations, CAPA management, change control, and document management (e.g., Trackwise, ComplianceWire, DocSpace) quality systems required.
- Experience leading/facilitating internal and external audits and provides leading role support during Health authority inspections required.
- Ability to write and/or effectively review/critique technical documents such as lab investigations with analytical and regulatory content as it relates to stability operations required.
- Understanding of laboratory systems/equipment (e.g., IQ/OQ/PQ/CSV) preferred.
- Experience operating as a leader with global mindset, understanding and appreciation of the global /enterprise context preferred.
- Influence, shaping solutions, negotiation and consultative skills are required.
- Ability to independently make difficult quality & compliance decisions required.
- Ability to define problems, collect data, establish facts and draw valid conclusions required.
- The ability to communicate clearly and concisely, both orally and in writing to all levels required.
- Ability to establish and maintain cooperative working relationships with internal and external partners required.
- Ability to take initiative and work independently while effectively managing timelines required.
- Ability to be positive, optimistic and enthusiastic change agent required!
- Ability to perform in fast paced environment and in stressful situations is required.
- This role supports both the Raritan and Titusville NJ Stability Lab locations, therefore routine travel between both sites is required. Additional domestic travel as needed required ~10%.
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.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan
JANSSEN SUPPLY GROUP, LLC (6046)