Senior Director CAPA

pAt 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. /ph3Job Function: /h3pQuality /ph3Job Sub Function: /h3pQuality Assurance /ph3Job Category: /h3pPeople Leader /ph3All Job Posting Locations: /h3pBeerse, Antwerp, Belgium, Cork, Cork, Ireland /ph3Job Description: /h3pPlease 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
- /ph3Position Summary /h3pThe 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. /ph3Key Responsibilities /h3ulliManage 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. /liliDevelop and implement an integrated strategy for continuous improvement. /liliServe as the champion for any investigation improvement initiatives across the network to ensure desired outcomes are achieved, in conjunction with key partners. /liliServe as the IM process owner of the quality escalation/notification system and technical solutions, such as trending tools. /liliServe as a champion to key business partners and stakeholders, facilitating quality, accountability, and a quality culture. /liliEnsure robust functional planning, balancing short-term objectives with long-term vision and sustainable resourcing strategies. /liliOversee the functioning of the IM NC/CAPA quality system and Issue Escalation processes to ensure management awareness, accountability, proactive actions, and effectiveness. /liliLead independent monitoring across IM NC/CAPA processes to drive short-term goals like inspection readiness and provide independent oversight of CAPA implementation. /liliEstablish 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. /liliPartner to ensure continued robust end-to-end process performance, providing escalation metrics and trending data to various QC organizations for evaluation. /liliInteract regularly with senior leaders in partner IM functions to ensure oversight and awareness of compliance status and key risks. /liliParticipate in and lead governance forums for NC/CAPA, maintaining robust escalation and review processes. /liliDevelop strategic imperatives and evolve functional capabilities to meet business needs. /liliMaintain documentation related to GxP activities in accordance with Johnson Johnson Quality Standards and local regulatory requirements. /liliReview and report on the performance of quality management systems at appropriate management levels. /liliSponsor key process and system-related projects aligned with the Innovative Medicine Quality System Strategy. /liliProvide strategic leadership and coaching to direct reports while overseeing a team of 35-40 personnel across the Americas, Europe, and ASPAC regions. /liliActively engage in industry forums and initiatives to benchmark against best practices and influence industry standards. /liliRequire 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. /li /ulh3Major Duties Responsibilities /h3h3Strategy, Governance Oversight /h3pEstablish and