Senior Director CAPA & Escalation (US)

6084-Janssen Research & Development Legal Entity•Horsham, PA

1d•$178,000 - $307,050•Onsite

About The Position

The Senior Director, CAPA and Escalations leads a global quality management strategy integrating CAPA processes, quality issue management, escalation activities, and process improvement across Innovative Medicine. The role ensures quality standards are met, risks are mitigated, and continuous improvement is applied throughout the product lifecycle. It owns the quality escalation and notification process and related technical solutions, and works with partner functions to strengthen investigation processes. The position oversees CAPA, issue management, escalation, and investigation processes for quality issues identified through audits, inspections, and internal sources. It establishes governance, metrics, monitoring, and follow-up processes to support compliance, management awareness, inspection readiness, accountability, and effective CAPA implementation. The role also collaborates with senior leaders and business partners, sponsors quality-system projects, maintains GxP documentation, and reports on quality-system performance. The Senior Director provides strategic leadership and coaching and oversees a global team of approximately 35–40 employees across the Americas, Europe, and ASPAC. The position is based in Horsham, Pennsylvania, and requires 20% travel.

Requirements

Bachelor’s degree in a relevant scientific or technical field.
At least 15 years of experience in Quality Management Systems, 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 in complex ecosystems.
Exceptional communication skills, including presenting to senior executives and articulating product vision.
Experience with quality systems such as document management, change control, deviation management, 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 translate complex concepts for varied stakeholders.
Strong planning and organizational skills, including priority setting.
Ability to work independently and as part of a team.
Demonstrated experience in a global matrix environment.
People management experience.
Ability to translate vision and strategy into executable outcomes.

Nice To Haves

Previous experience with budget management, resource management, and capacity planning.
Good understanding of GxP and Computerized System Validation requirements.
Experience in a manufacturing environment.
Experience leading diverse, multidisciplinary teams, directly and indirectly.
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

Lead a global team responsible for end-to-end CAPA, issue management, escalation, and investigation processes for Innovative Medicine quality issues.
Develop and implement an integrated strategy for continuous improvement and investigation improvement initiatives across the network.
Own the Innovative Medicine quality escalation and notification system and associated technical solutions, including trending tools.
Champion quality, accountability, and a strong quality culture with business partners and stakeholders.
Plan functional priorities and resourcing, balancing immediate objectives with long-term, sustainable needs.
Oversee the Innovative Medicine nonconformance/CAPA quality system and issue escalation processes to promote management awareness, accountability, proactive action, and effectiveness.
Lead independent monitoring of nonconformance/CAPA processes, supporting inspection readiness and independent oversight of CAPA implementation.
Establish global governance to track and manage nonconformance/CAPA processes and metrics, including follow-up when commitments are not met.
Provide escalation metrics and trending data to Quality & Compliance organizations and partner to maintain end-to-end process performance.
Engage senior leaders in partner functions regarding compliance status and key risks.
Participate in and lead nonconformance/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 company quality standards and local regulatory requirements.
Review and report quality management system performance to appropriate management levels.
Sponsor process- and system-related projects aligned with the Innovative Medicine Quality System Strategy.
Provide strategic direction and coaching to direct reports and oversee a team of approximately 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 global governance for quality management systems, including CAPA, escalation, and issue management.
Monitor QMS compliance and effectiveness, ensuring alignment with regulatory requirements and best practices.
Represent the organization in governance forums and audits.
Lead quality issue and nonconformance management, ensuring timely escalation and resolution.
Implement and monitor quality metrics and KPIs to assess performance and identify improvement opportunities.
Develop and deploy holistic quality processes across functions.
Collaborate with stakeholders, including R&D, Regulatory Affairs, and Operations, to integrate quality processes across the organization.
Facilitate communication and alignment on quality priorities across business functions.
Build and lead a diverse global team, fostering a high-performance culture focused on accountability and results.
Coach and provide strategic direction to direct reports, supporting their professional development.

Benefits

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 different amounts 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 the birth, adoption, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.