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. 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. /ppJob Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Schaffhausen, Switzerland /ppPlease 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 /h3ulliEstablish and oversee a global governance framework for quality management systems (QMS), including CAPA, Escalation and issue management processes. /liliMonitor compliance and oversee the effectiveness of QMS, ensuring alignment with regulatory requirements and best practices. /liliDevelop strategic imperatives for quality management to ensure alignment with organizational goals and regulatory standards. /liliRepresent the organization in relevant governance forums and audits to maintain compliance and drive quality excellence. /li /ulh3Quality Issue Management /h3ulliLead the management of quality issues and nonconformance, ensuring timely escalation and resolution. /liliImplement and monitor robust metrics and KPIs to measure quality performance and identify areas for continuous improvement. /li /ulh3Process Management and Continuous Improvement /h3ulliDevelop and deploy holistic quality processes across multiple functions. /li /ulh3Stakeholder Management and Collaboration /h3ulliCollaborate with internal stakeholders (RD, Regulatory Affairs, Operations) to integrate quality processes organization-wide. /liliAct as a conduit between business functions to facilitate communication and alignment on quality priorities. /li /ulh3People Management /h3ulliBuild and lead a diverse, global team of quality professionals, fostering a high-performance culture focused on accountability and results. /liliProvide coaching and strategic direction to direct reports, encouraging professional development. /li /ulh3Required Minimum Education /h3ulliBachelor’s Degree in a relevant scientific or technical field /li /ulh3Required Years of Related Experience /h3ulliA 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. /li /ulh3Required Knowledge, Skills and Abilities /h3ulliStrong leader with the ability to establish clear strategy that can inspire others to deliver and influence to drive change across the organization /liliExperience in supporting Quality Compliance organizations on their management systems journey. /liliConsistent track record of collaboration, including the ability to work with cross-functional teams, and across complex ecosystems /liliExceptional communications skills (including articulating product vision, inspiring teams, and presenting to senior executives). /liliExperience working with Quality Systems is essential (Document Management, Change Control, Deviation and CAPA Management, etc.) at a process, platform and execution level /liliStrong negotiation and interpersonal skills required /liliExcellent stakeholder management and networking skills required /liliExperience leading and implementing change strategies /liliExperience leading complex projects required /liliFinancial Acumen required /liliExcellent written and verbal communications skills in English required /liliAbility to translate complex concepts for a variety of stakeholders required /liliStrong planning and organizational skills with a good understanding of priority setting required /liliAbility to work independently but also in a team required /liliProven track record working in a global matrix environment required /liliPeople management experience required /liliAbility to translate vision and strategy into executable outcomes /li /ulh3Preferred Knowledge, Skills and Abilities /h3ulliPrevious experience with budget, resource management and capacity planning preferred /liliGood understanding of GxP and Computerized System Validation requirements /liliExperience in manufacturing environment /liliExperience in leading diverse, muti-disciplinary teams (direct and indirect) /liliOperational experience /liliProcess excellence certification (e.g. SixSigma, LEAN, or DEX green or black belt) /liliStrong sector AND global mindset /liliStrong business acumen /li /ulh3Percentage Traveled /h3ulli20% /li /ulpJohnson 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 ( ) or contact AskGS to be directed to your accommodation resource. /ph3Required Skills /h3ulliCompliance Management /liliCorrective and Preventive Action (CAPA) /liliDeveloping Others /liliFact-Based Decision Making /liliGive Feedback /liliGood Manufacturing Practices (GMP) /liliInclusive Leadership /liliISO 9001 /liliLeadership /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliStrategic Thinking /liliSuccession Planning /liliTactical Thinking /li /ulh3Preferred Skills /h3ulliCompliance Management /liliCorrective and Preventive Action (CAPA) /liliDeveloping Others /liliFact-Based Decision Making /liliGive Feedback /liliGood Manufacturing Practices (GMP) /liliInclusive Leadership /liliISO 9001 /liliLeadership /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliQuality Validation /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliStrategic Thinking /liliSuccession Planning /liliTactical Thinking /li /ulpAt 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 /p #J-18808-Ljbffr