Senior Director CAPA & Escalation

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.

What You Will Do

Key responsibilities include managing a global team, developing and implementing an integrated strategy for continuous improvement, and serving as the IM process owner of the quality escalation/notification system and technical solutions.

Why It Might Be a Fit

The successful candidate will also ensure the robustness of investigation improvement processes in collaboration with partner functions and provide strategic leadership and coaching to direct reports.

Requirements

• Bachelor's Degree in a relevant scientific or technical field
• 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.
• 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

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year