Senior Manager, Clinical Program Quality and Excellence (Oncology)

About the role

For our client, we are seeking a Senior Manager, Clinical Program Quality and Excellence (Oncology) to join the team of a leader in the Pharmaceuticals & Biotech space. This role will provide quality assurance leadership across global clinical research programs, with a strong emphasis on oncology development. The Senior Manager will partner closely with clinical teams to strengthen inspection readiness, manage GCP compliance risks, and support the delivery of high-quality clinical operations. This position also plays an important role in audit strategy, issue resolution, and the reporting of program metrics that inform development teams.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Provide quality assurance oversight of global clinical research programs
• Serve as a strategic quality thought partner to clinical teams
• Define and implement risk-based audit strategy and communicate compliance risks
• Lead clinical pre-approval inspection readiness and follow-up actions
• Investigate significant quality issues and ensure corrective actions are tracked
• Assist in managing GCP health authority inspections and provide technical support
• Analyze and report program metrics to development teams

Qualifications

• BS/BA required; advanced degree preferred
• 7+ years in the pharmaceutical, biotechnology, or health care industry
• 5+ years of GCP-related Quality Assurance or clinical trial experience
• In-depth knowledge of ICH GCP R2 and global regulations
• Advanced auditing skills for complex assignments
• Strong technical writing and communication skills
• Judgment and project management abilities, with a keen attention to detail

Benefits

• Work in a virtual environment
• Opportunities for professional development and growth
• Potential for internal career advancement
• Supportive and collaborative work culture
• Inclusive workplace with a commitment to diversity

Pay

$137,000 – $215,270 annually