Senior Director CAPA & Escalation (US)

Johnson & Johnson•Horsham, PA

16h•$178,000 - $307,050

About The Position

The Senior Director, CAPA and Escalations develops and leads an integrated quality management strategy covering CAPA, quality issue management, escalation, and process improvement across the organization. The role ensures quality standards are met, risks are mitigated, and continuous improvement is implemented throughout the product lifecycle. It also oversees investigation improvement processes in collaboration with partner functions and owns the process and system components of quality escalation and notification activities. The position leads a diverse global team responsible for CAPA, issue management, escalation, and investigation processes for Innovative Medicine (IM) quality issues originating from audits, inspections, and self-identified sources. It oversees the IM nonconformance/CAPA quality system and issue escalation processes; establishes governance, metrics, monitoring, and follow-up; and partners across the organization to support compliance, accountability, inspection readiness, and effective CAPA implementation. The role provides strategic direction and coaching to direct reports and oversees 35–40 personnel across the Americas, Europe, and ASPAC. It also sponsors quality-system projects, maintains GxP documentation, reports on quality-system performance, and participates in industry forums and initiatives. The position involves 20% travel.

Requirements

Bachelor’s degree in a relevant scientific or technical field.
At least 15 years of experience in QMS, operations management, regulatory compliance, or a related field, with strong knowledge of CAPA processes.
Ability to establish a clear strategy, inspire others, and influence organizational change.
Experience supporting Quality & Compliance organizations in their management systems journey.
Demonstrated collaboration with cross-functional teams and complex ecosystems.
Exceptional communication skills, including presenting to senior executives and articulating vision.
Experience with quality systems such as document management, change control, deviation, and CAPA management at process, platform, and execution levels.
Strong negotiation and interpersonal skills.
Strong stakeholder management and networking skills.
Experience leading and implementing change strategies.
Experience leading complex projects.
Financial acumen.
Excellent written and verbal communication skills in English.
Ability to explain complex concepts to varied stakeholders.
Strong planning and organizational skills, including priority setting.
Ability to work independently and as part of a team.
Proven experience working in a global matrix environment.
People management experience.
Ability to translate vision and strategy into executable outcomes.

Nice To Haves

Previous experience with budgets, resource management, and capacity planning.
Good understanding of GxP and computerized system validation requirements.
Experience in a manufacturing environment.
Experience leading diverse multidisciplinary teams, both direct and indirect.
Operational experience.
Process excellence certification, such as Six Sigma, LEAN, or DEX Green or Black Belt.
Strong sector and global mindset.
Strong business acumen.

Responsibilities

Manage a diverse global team with end-to-end responsibility for CAPA, issue management, escalation, and investigation processes for IM-related quality issues.
Develop and implement an integrated strategy for continuous improvement.
Lead investigation improvement initiatives across the network in collaboration with partners.
Own the IM quality escalation and notification system and related technical solutions, including trending tools.
Champion quality, accountability, and a strong quality culture with business partners and stakeholders.
Plan functional priorities and resources, balancing short-term objectives with long-term needs.
Oversee IM nonconformance/CAPA and issue escalation processes to ensure management awareness, accountability, proactive action, and effectiveness.
Lead independent monitoring of IM NC/CAPA processes, supporting inspection readiness and independent oversight of CAPA implementation.
Establish global governance to track and manage NC/CAPA processes and metrics, including follow-up when commitments are not met.
Provide escalation metrics and trending data to Q&C organizations and partner to sustain end-to-end process performance.
Engage senior leaders in partner IM functions regarding compliance status and key risks.
Participate in and lead NC/CAPA governance forums and maintain effective escalation and review processes.
Develop strategic imperatives and functional capabilities aligned with business needs.
Maintain GxP documentation in accordance with Johnson & Johnson Quality Standards and local regulatory requirements.
Review and report quality management system performance at appropriate management levels.
Sponsor process- and system-related projects aligned with the Innovative Medicine Quality System Strategy.
Provide strategic leadership and coaching to direct reports and oversee a team of 35–40 people across the Americas, Europe, and ASPAC.
Participate in industry forums and initiatives to benchmark practices and influence industry standards.
Ensure implementation or remediation activities for named quality systems are planned to meet new or revised internal or external quality requirements within Segment QMSs.
Establish and oversee a global QMS governance framework covering CAPA, escalation, and issue management.
Monitor QMS compliance and effectiveness, aligning processes with regulatory requirements and best practices.
Represent the organization in governance forums and audits.
Lead quality issue and nonconformance management to ensure timely escalation and resolution.
Develop and monitor quality metrics and KPIs to measure performance and identify improvement opportunities.
Develop and deploy holistic quality processes across functions.
Collaborate with internal stakeholders, including R&D, Regulatory Affairs, and Operations, and facilitate alignment on quality priorities.
Build and lead a diverse global team, fostering accountability, results, and professional development.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified higher allowances for employees residing in Colorado or Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental leave: 480 hours within one year of a child’s birth, adoption, or foster-care placement.
Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver leave: 80 hours in a rolling 52-week period.
Volunteer leave: 32 hours per calendar year.
Military spouse time off: 80 hours per calendar year.