Johnson & Johnson Careers
QMS Oversight Lead
Requisition ID: 00001EOL
Janssen Pharmaceutical, a Johnson & Johnson Company, is recruiting for a QMS Oversight Lead, to be located in Raritan, NJ; Titusville, NJ; Skillman, NJ; New Brunswick, NJ; Horsham, PA; Spring House, PA; Beerse, Belgium; or High Wycombe, UK.
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.
This position will serve as a critical role in the BioResearch Quality & Compliance (BRQC) Janssen organization to drive quality excellence in Quality Issue records. This position will lead and contribute to identification of risks within quality and compliance and implement appropriate mitigation actions across the R&D QMS. In addition, this position will lead innovative development initiatives across BRQC by leveraging internal capabilities.
This individual will report into the Head of QMS Oversight Lead in BRQC Janssen, and will participate in and support various business issues, strategic and organizational development, as required by business urgency and organizational growth. The scope is across various R&D functions, segments and specifically BRQC Janssen, and requires significant collaboration, alignment, and influencing. They will act independently and with high impact to drive results and organizational performance. He or she will seek guidance only as needed on new assignments and understand the sense of urgency related to activities. He or she will develop and implement strategies related to job description core areas.
- Drive process for executing quality excellence in Quality Issue records
- Collaborate with BRQC Janssen functional areas to support identification of risks within quality and compliance and implement appropriate mitigation actions across the R&D QMS
- Support key business partners and stakeholders to liaise between quality groups, and governance to enable and promote quality, accountability and quality culture
- Develop, plan, and measure programs for defined QMS Oversight activities such as CAPA management, quality issue management, monitoring, risk remediation and vendor CAPA oversight
- Manage an escalation method to support global GxP CAPA governance, and support the escalation of individual CAPAs at risk and/or negative trends in Critical to Quality measures
- Support investigations of large-scale significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate
- Support interactions with key senior leaders to maintain executive awareness of GxP Quality Issue and CAPA performance
- Manage defined thresholds enabling the tracking/trending of escalated issues across the QMS holistically inclusive of CAPA escalations to leadership councils or forums
- Lead Regulatory Inspection readiness initiatives and activities across GxP disciplines/segments, as appropriate
- Manage, prioritize and execute team-led strategic initiatives, including the development of communication plans for various levels of management, key milestones and deliverables for short and long-term goals
- Lead and support BRQC driven People Excellence initiatives and create innovative talent development activities by leveraging internal capabilities
- Create surveys, collate, and analyze data into concise reports for process improvement initiatives
- Plan, organize, and drive departmental meetings, including scheduling advancement topics and engaging external presenters
- Manage knowledge share opportunities sponsored by QMS Oversight, such as Lunch & Learns and Video Learning opportunities
- A Bachelor’s degree (or University equivalent) is required; A Master’s degree, or Advanced Degree is preferred
- A minimum of 8 years of experience inclusive of Quality & Project Management, or related experience is required
- Ability to build effective relationships across internal and external partners, collaboration and experience in building strong communication with key partners while bringing a sense of urgency to the critical needs of the business is required.
- Ability to organize and present information concisely to a variety of audiences is required
- Demonstrated ability to be proactive, exercise independent judgment and demonstrated ability to work effectively on cross-functional teams with all levels of personnel is required
- Proven change management, project team leadership, and knowledge of factors that influence human behavior and decision-making at the individual, group, and organizational level is required
- Demonstrated excellence in project management and effective management of multiple projects and priorities is required
- Excellent leadership, influence management, and collaboration skills, as well as a demonstrated competency interfacing with senior leaders is required
- Experience in identifying, designing, and executing training solutions in a variety of formats (in person, virtual, eLearning) to apply strategic adult learning principles is preferred.
- Performance driven, but collaborative functional leader – respected and respectful is required.
- Knowledge using a Document Management System (e.g., SharePoint) is preferred
- Experience working with senior leaders/leadership teams is required
- Experience in operational activities in a compliance environment is preferred
- Strong networking and relationship building skills is required
- Proactive strategic thinker with strong problem-solving skills is required
- This position will be located in Raritan, NJ; Titusville, NJ; Skillman, NJ; New Brunswick, NJ; Horsham, PA; Spring House, PA; Beerse, Belgium; or High Wycombe, UK, and may require up to 25% domestic and international travel
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-Raritan-
United States-New Jersey-Titusville, United Kingdom-England-High Wycombe, North America-United States-New Jersey-New Brunswick, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, United States-New Jersey-Skillman
Janssen Research & Development, LLC. (6084)