Senior Director CAPA

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

People Leader

All Job Posting Locations

Beerse, Antwerp, Belgium, Cork, Cork, Ireland

Job Description

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

USA Req#: R-

Belgium/Ireland Req#: R-

Switzerland Req#: R-

Position Summary

The Senior Director, CAPA and Escalations is responsible for developing and leading a comprehensive quality management strategy that integrates CAPA processes, quality issue management, and innovative process improvements across the organization. This role will ensure quality standards are met, risks are mitigated, and continuous improvement initiatives are implemented throughout the product lifecycle. The successful candidate will also ensure the robustness of investigation improvement processes in collaboration with partner functions. This position is also responsible for managing all process and system components of the escalation/notification activities that fall under the quality escalation procedure.

Key Responsibilities

• Manage a diverse, global team with end-to-end CAPA, Issue Management, Escalation, and Investigation process responsibility for IM-related quality issues from audits, inspections, and self-identified sources.
• Develop and implement an integrated strategy for continuous improvement.
• Serve as the champion for any investigation improvement initiatives across the network to ensure desired outcomes are achieved, in conjunction with key partners.
• Serve as the IM process owner of the quality escalation/notification system and technical solutions, such as trending tools.
• Serve as a champion to key business partners and stakeholders, facilitating quality, accountability, and a quality culture.
• Ensure robust functional planning, balancing short-term objectives with long-term vision and sustainable resourcing strategies.
• Oversee the functioning of the IM NC/CAPA quality system and Issue Escalation processes to ensure management awareness, accountability, proactive actions, and effectiveness.
• Lead independent monitoring across IM NC/CAPA processes to drive short-term goals like inspection readiness and provide independent oversight of CAPA implementation.
• Establish an efficient governance program to track and manage IM NC/CAPA processes and metrics globally and an effective follow-up strategy if commitments are not being met.
• Partner to ensure continued robust end-to-end process performance, providing escalation metrics and trending data to various Q&C organizations for evaluation.
• Interact regularly with senior leaders in partner IM functions to ensure oversight and awareness of compliance status and key risks.
• Participate in and lead governance forums for NC/CAPA, maintaining robust escalation and review processes.
• Develop strategic imperatives and evolve functional capabilities to meet business needs.
• Maintain documentation related to GxP activities in accordance with Johnson & Johnson Quality Standards and local regulatory requirements.
• Review and report on the performance of quality management systems at appropriate management levels.
• Sponsor key process and system-related projects aligned with the Innovative Medicine Quality System Strategy.
• Provide strategic leadership and coaching to direct reports while overseeing a team of 35-40 personnel across the Americas, Europe, and ASPAC regions.
• Actively engage in industry forums and initiatives to benchmark against best practices and influence industry standards.
• Require that implementation and/or remediation activities on named quality systems be planned in order to comply with a new or revised internal or external quality requirement within Segment QMS’s.

Major Duties & Responsibilities

• Strategy, Governance & Oversight: Establish and oversee a global governance framework for quality management systems (QMS), including CAPA, Escalation and issue management processes.
• Monitor compliance and oversee the effectiveness of QMS, ensuring alignment with regulatory requirements and best practices. Develop strategic imperatives for quality management to ensure alignment with organizational goals and regulatory standards.
• Represent the organization in relevant governance forums and audits to maintain compliance and drive quality excellence.
• Quality Issue Management: Lead the management of quality issues and nonconformance