Senior Director CAPA & Escalation (US)

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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.
• 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, ensuring timely escalation and resolution.
• Implement and monitor robust metrics and KPIs to measure quality performance and identify areas for continuous improvement.
• Process Management and Continuous Improvement: Develop and deploy holistic quality processes across multiple functions.
• Stakeholder Management and Collaboration: Collaborate with internal stakeholders (R&D, Regulatory Affairs, Operations) to integrate quality processes organization-wide.
• Act as a conduit between business functions to facilitate communication and alignment on quality priorities.
• People Management:  Build and lead a diverse, global team of quality professionals, fostering a high-performance culture focused on accountability and results.
• Provide coaching and strategic direction to direct reports, encouraging professional development.

Required Minimum Education: Bachelor’s Degree in a relevant scientific or technical field

Required Years of Related Experience: A minimum of 15 Years of experience in Quality Management Systems (QMS), Operations Management, regulatory compliance, or a related field, with strong knowledge of CAPA processes.

Required Knowledge, Skills and Abilities:

• Strong leader with the ability to establish clear strategy that can inspire others to deliver and influence to drive change across the organization 
• Experience in supporting Quality & Compliance organizations on their management systems journey. 
• Consistent track record of collaboration, including the ability to work with cross-functional teams, and across complex ecosystems 
• Exceptional communications skills (including articulating product vision, inspiring teams, and presenting to senior executives). 
• Experience working with Quality Systems is essential (Document Management, Change Control, Deviation and CAPA Management, etc.) at a process, platform and execution level 
• Strong negotiation and interpersonal skills required  
• Excellent stakeholder management and networking skills required 
• Experience leading and implementing change strategies 
• Experience leading complex projects required 
• Financial Acumen required 
• Excellent written and verbal communications skills in English required 
• Ability to translate complex concepts for a variety of stakeholders required 
• Strong planning and organizational skills with a good understanding of priority setting required 
• Ability to work independently but also in a team required 
• Proven track record working in a global matrix environment required 
• People management experience required 
• Ability to translate vision and strategy into executable outcomes 

Preferred Knowledge, Skills and Abilities:

• Previous experience with budget, resource management and capacity planning preferred 
• Good understanding of GxP and Computerized System Validation requirements 
• Experience in manufacturing environment 
• Experience in leading diverse, muti-disciplinary teams (direct and indirect)  
• Operational experience 
• Process excellence certification (e.g. SixSigma, LEAN, or DEX green or black belt) 
• Strong sector AND global mindset 
• Strong business acumen 

Percentage Traveled: 20%

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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