Lead a global team of Clinical QA Program Leads and drive cross-functional partnerships in a highly matrixed organization
Drive and deliver audit strategies/capabilities across all GCP audit types
Conduct GCP audits & support GxP Audits including resolution of CAPAs when applicable
Serve as the primary contact for Clinical QA related to HA Inspections
Mentor Clinical QA team members to support talent development and training
Take an active role in, and lead, projects and teams in key project initiatives across the organization

A minimum of a Bachelor of Science (BSc) degree is required with a focus in science, life science or pharmaceutical science is required
An advanced degree (M.D, Ph.D, MSc or Pharm D) would be desirable
Deep knowledge and understanding of the drug development process, GxP functional compliance regulations (national and international)
Sound research and development practices, scientific terminology, company quality assurance procedures and policies, and quality evaluation techniques
Excellent communication, organization, investigation, and negotiation skills, and be diplomatic
Advanced problem-solving skills
Advanced strategic thinking related to new and emerging technologies and analytics
A track record of leading global strategic initiatives in the R&D Quality and Compliance areas
Experience of leading and advancing a global team of direct reports
A minimum of 12 years relevant work experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP regulated discipline)

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Director, Clinical Audit Strategy

Key skills