Senior Director CAPA & Escalation (BE/IE)

Johnson & Johnson Co.; Cork; On-site; EUR 150,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Director, CAPA and Escalations, to lead a global quality management program across IM NC/CAPA, CAPA, issue management, and escalation processes. The role partners with senior leaders to strengthen quality, risk management, and continuous improvement across the product lifecycle.

The successful candidate will own the escalation/notification systems, drive investigation improvements, and build a governance framework to track metrics globally, ensuring

Responsibilities

• Manage a global team with end-to-end CAPA, Issue Management, Escalation, and Investigation for IM-related quality issues from audits, inspections, and self-identified sources.
• Develop and implement an integrated strategy for continuous improvement.
• Champion investigation improvement initiatives across the network with key partners.
• Owner of the quality escalation/notification system and related technical solutions, such as trending tools.
• Champion to key business partners, promoting quality, accountability, and a quality culture.
• Ensure robust functional planning balancing short- and long-term objectives and sustainable resourcing.
• Oversee IM NC/CAPA quality system and Issue Escalation processes to ensure management awareness and effectiveness.
• Lead independent monitoring across IM NC/CAPA processes to drive inspection readiness and CAPA oversight.
• Establish governance to track IM NC/CAPA processes globally and follow up on commitments.
• Provide escalation metrics and trending data to Q&C organizations for evaluation.

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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-103879

Belgium/Ireland Req#: R-105124

Switzerland Req#: R-105123

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.