[Innovative Medicine] Sr. QA Specialist, IMSC NC CAPA

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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.

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The Sr. Quality Specialist leads robustness of NC/CAPA investigations and approvals ensuring timely initiation thorough root-cause analysis and effective corrective/preventive actions across Innovative Medicine Supply Chain sites. This skilled and competent Quality Investigator and Approver role will support monitoring progress provide feedback to investigation and CAPA owners resolve stakeholder conflicts and escalate issues to senior management when required.

NC CAPA Quality System Investigation Process: Supply Chain Implementation

• Support efficient and effective investigation training/certification. Support NC/CAPA system and process user training

• Facilitate the initiation of investigations and CAPAs and monitor progress and approvals.

• Collaborate with key stakeholders to support the end-to-end NC/CAPA process.

• Support NC/CAPA system and process user training including investigation certification.

• Facilitate initiation of investigations and CAPAs and monitor progress to ensure timely completion.

• Execute quality reviewer/approver duties review evidence and approve closure of NC and CAPA records.

• Conduct investigation record quality reviews for documentation completeness robust root-cause analysis and compliance with procedures.

• Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level.

• Use data analytics and trending to identify failure modes measure CAPA effectiveness and inform continuous improvement priorities.

• Compile and provide regular CAPA status updates metric reports and trending analyses.

• Collaborate with stakeholders site owners governance bodies and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues to the Senior Manager Quality Systems CAPA as needed.

• Coordinate with IMSC sites and responsible functions to drive completion of assigned actions.

• Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.

• Ensure the IMSC NC/CAPA process remains inspection-ready and support audits/inspections.

• Provide coaching and actionable feedback to issue owners on CAPA best practices system usage and investigation execution.

• Participate in and/or support internal audits and regulatory inspections as needed.

• Attend participate and/or facilitate SC NC CAPA review meetings as needed.

• Perform other duties as necessary.

DECISION-MAKING AND PROBLEM-SOLVING:

• Ability to work independently and coordinate across Supply Chain driving compliance to the NC CAPA Global Process.
• Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations.
• A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions.
• Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals.
• Requires data analytical skills to examine data and perform analysis.
• Requires decision-making skills to approve the appropriateness effectiveness quality and compliance of documented robust investigations root cause analysis and corrective/preventative action plans.

REPORTING RELATIONSHIPS:

• The position reports directly to the Senior Manager SC Quality Systems NC CAPA.

WORKING RELATIONSHIPS/INTERFACES:

• Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis.
• Senior Manager/Director NC CAPA interfaces and informs as needed to discuss issues.
• CAPA and Issue Management team members interfaces daily as needed to manage workload interfaces weekly in team meetings.
• Supply Chain Global Quality Systems R&D Senior Management R&D Quality Regulatory Affairs Medical Affairs and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and provide guidance on established processes.
• J&J partners must be able to effectively interact with third-party organizations and marketing partners as needed to address cross-company and cross-departmental issues.

EDUCATION & EXPERIENCE REQUIREMENTS:

• Bachelors Degree in Life Science or related discipline or equivalent is required.
• Knowledge and experience with regulations and regulatory compliance issues.
• Minimum of 6 years experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field and/or equivalent experience/training in a related NC CAPA Investigation Quality System area.
• Demonstrated experience as an investigator of Non-Conformance/CAPA process.
• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.
• Requires critical analytical and problem-solving skills strategic thinker and collaborator.
• Excellent organization prioritization and time management skills.
• Demonstrated competencies include adaptability attention to detail and ability to build and maintain relationships and partnerships across the organization.
• Ability to build and maintain cross-functional interactions and coordination.
• Ability to build consensus influence and negotiate.
• Knowledge of Quality Management Project Management and/or Process Excellence concepts and practices.
• Other core skills: strong attention to detail excellent time management relationship-building and experience with CAPA systems investigative techniques and data-driven quality improvement.

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