Senior Director CAPA & Escalation (CH)

pAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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. /p pAs 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. /p h3Job Function /h3 pQuality /p h3Job Sub Function /h3 pQuality Assurance /p h3Job Category /h3 pPeople Leader /p h3All Job Posting Locations /h3 pSchaffhausen, Switzerland /p h3Position Summary /h3 pThe 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. /p h3Key Responsibilities /h3 ul liManage 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. /li liDevelop and implement an integrated strategy for continuous improvement. /li liServe as the champion for any investigation improvement initiatives across the network to ensure desired outcomes are achieved, in conjunction with key partners. /li liServe as the IM process owner of the quality escalation/notification system and technical solutions, such as trending tools. /li liServe as a champion to key business partners and stakeholders, facilitating quality, accountability, and a quality culture. /li liEnsure robust functional planning, balancing short-term objectives with long-term vision and sustainable resourcing strategies. /li liOversee the functioning of the IM NC/CAPA quality system and Issue Escalation processes to ensure management awareness, accountability, proactive actions, and effectiveness. /li liLead independent monitoring across IM NC/CAPA processes to drive short-term goals like inspection readiness and provide independent oversight of CAPA implementation. /li liEstablish 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. /li liPartner to ensure continued robust end-to-end process performance, providing escalation metrics and trending data to various QC organizations for evaluation. /li liInteract regularly with senior leaders in partner IM functions to ensure oversight and awareness of compliance status and key risks. /li liParticipate in and lead governance forums for NC/CAPA, maintaining robust escalation and review processes. /li liDevelop strategic imperatives and evolve functional capabilities to meet business needs. /li liMaintain documentation related to GxP activities in accordance with Johnson Johnson Quality Standards and local regulatory requirements. /li liReview and report on the performance of quality management systems at appropriate management levels. /li liSponsor key process and system-related projects aligned with the Innovative Medicine Quality System Strategy. /li liProvide strategic leadership and coaching to direct reports while overseeing a team of 35-40 personnel across the Americas, Europe, and ASPAC regions. /li liActively engage in industry forums and initiatives to benchmark against best practices and influence industry standards. /li liRequire 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 /ul h3Major Duties Responsibilities /h3 ul liStrategy, Governance Oversight: Establish and oversee a global governance framework for quality management systems (QMS), including CAPA, Escalation and issue management processes. /li liMonitor 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. /li liRepresent the organization in relevant governance forums and audits to maintain compliance and drive quality excellence. /li liQuality Issue Management: Lead the management of quality issues and nonconformance, ensuring timely escalation and resolution. /li liImplement and monitor robust metrics and KPIs to measure quality performance and identify areas for continuous improvement. /li liProcess Management and Continuous Improvement: Develop and deploy holistic quality processes across multiple functions. /li liStakeholder Management and Collaboration: Collaborate with internal stakeholders (RD, Regulatory Affairs, Operations) to integrate quality processes organization-wide. /li liAct as a conduit between business functions to facilitate communication and alignment on quality priorities. /li liPeople Management: Build and lead a diverse, global team of quality professionals, fostering a high-performance culture focused on accountability and results. /li liProvide coaching and strategic direction to direct reports, encouraging professional development. /li /ul h3Required Minimum Education /h3 pBachelor's Degree in a relevant scientific or technical field /p h3Required Years of Related Experience /h3 pA 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. /p h3Required Knowledge, Skills and Abilities /h3 ul liStrong leader with the ability to establish clear strategy that can inspire others to deliver and influence to drive change across the organization /li liExperience in supporting Quality Compliance organizations on their management systems journey. /li liConsistent track record of collaboration, including the ability to work with cross-functional teams, and across complex ecosystems /li liExceptional communications skills (including articulating product vision, inspiring teams, and presenting to senior executives). /li liExperience working with Quality Systems is essential (Document Management, Change Control, Deviation and CAPA Management, etc.) at a process, platform and execution level /li liStrong negotiation and interpersonal skills required /li liExcellent stakeholder management and networking skills required /li liExperience leading and implementing change strategies /li liExperience leading complex projects required /li liFinancial Acumen required /li liExcellent written and verbal communications skills in English required /li liAbility to translate complex concepts for a variety of stakeholders required /li liStrong planning and organizational skills with a good understanding of priority setting required /li liAbility to work independently but also in a team requiredProven track record working in a global matrix environment required /li liPeople management experience required /li liAbility to translate vision and strategy into executable outcomes /li /ul h3Preferred Knowledge, Skills and Abilities /h3 ul liPrevious experience with budget, resource management and capacity planning preferred /li liGood understanding of GxP and Computerized System Validation requirements /li liExperience in manufacturing environment /li liExperience in leading diverse, muti-disciplinary teams (direct and indirect) /li liOperational experience /li liProcess excellence certification (e.g. SixSigma, LEAN, or DEX green or black belt) /li liStrong sector AND global mindset /li liStrong business acumen /li /ul h3Percentage Traveled /h3 pb20% /b /p pJohnson 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. /p pJohnson 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 or contact AskGS to be directed to your accommodation resource. /p h3Preferred Skills /h3 pCompliance Management, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Strategic Thinking, Succession Planning, Tactical Thinking /p #J-18808-Ljbffr