Associate Director, Clinical Program Quality and Excellence (Oncology)
About the role
For our client, we are seeking an Associate Director, Clinical Program Quality and Excellence (Oncology) to join the team of a leader in the Pharmaceuticals & Biotech space. This role will guide quality assurance strategy across global clinical research programs with a strong focus on oncology. The Associate Director will partner closely with Clinical Program Teams to provide risk-based quality expertise, strengthen compliance, and support inspection readiness throughout the clinical development lifecycle. This position is well suited for a senior quality professional who can translate global regulations and GCP expectations into practical program-level action. Location: Remote - US based candidates only, no visa sponsorship available.
Responsibilities
- Oversee quality assurance for global clinical research programs
- Advise Clinical Program Teams on quality expertise and risk-based guidance
- Define and implement risk-based audit strategies under guidance
- Lead pre-approval inspection readiness and mitigate compliance risks
- Develop and manage program-specific compliance strategies with advanced auditing
Qualifications
- BA/BS required; advanced degree preferred
- 10+ years in the pharmaceutical, biotechnology, or healthcare industry
- 7+ years of GCP-related Quality Assurance or clinical trial experience
- Extensive knowledge of ICH GCP and global clinical development regulations
- Advanced auditing skills and experience developing corrective action plans
Benefits
- Comprehensive benefits package offering health and wellness resources
- Flexible work arrangements, including a virtual office setup
- Career development opportunities and support for continued education
- Travel opportunities for international audits and inspections
Pay
$154,400 – $242,550 annually