Senior Director, Clinical Operations Compliance Management ( Sr. Director of Quality GCP)
Green Key Resources | Alameda County, CA | Onsite | Full Time Permanent - Great Relocation Package Available
About the Opportunity
We are partnering exclusively with a leading oncology biotech headquartered in Alameda County, CA with a stunning bay-view campus and a culture built on collaboration, accountability, and scientific excellence. We are seeking a Senior Director of Clinical Operations Compliance Management to join their Clinical Operations team. This is a high-impact leadership role for a seasoned GCP compliance and risk management professional who thrives in a fast-paced, roll-up-your-sleeves biotech environment.
This is not a hands-on study management role. This position is specifically focused on building and leading the compliance and risk governance infrastructure that enables consistent, high-quality clinical trial execution across a portfolio of complex oncology programs.
About the Role
The Senior Director of Clinical Operations Compliance Management is a key partner to the Quality Assurance team and Clinical Operations leadership, responsible for embedding a risk and issue management culture across the organization. You will define strategy, drive cross-study process standardization, lead inspection readiness initiatives, and serve as the escalation point for operational quality issues across the clinical development portfolio.
Key Responsibilities
Lead the design and operationalization of clinical risk and issue management frameworks aligned with ICH GCP and FDA regulatory standards, ensuring cross-study consistency and inspection readiness at all times
- Drive CAPA oversight for Clinical Operations including root cause analysis, owner assignment, follow-up, and completion tracking, providing leadership with regular status updates
- Partner closely with Quality Assurance to support audit readiness, regulatory inspections including BIMO, and compliance with ICH GCP and applicable local regulations
- Oversee vendor and CRO governance including performance monitoring, KPI development, risk identification, and corrective action management across the supplier landscape
- Analyze trends and compliance data across studies and provide meaningful reporting to Clinical Operations leadership to drive smart risk-based decision making
- Standardize cross-functional processes, templates, and tools used by Clinical Operations teams to drive consistency and reduce variability in study execution
- Support development and use of clinical systems managed by the Clinical Operations function including dashboards, metrics, and digital tools for operational insights
- Lead and develop a team of direct reports and consultants, fostering a culture of quality, accountability, and continuous improvement
What You Will Bring
- 15 or more years of experience in clinical operations or clinical quality within the pharmaceutical or biotechnology industry with a focus on compliance governance and risk management rather than hands-on study management
- Deep expertise in ICH GCP, risk-based quality management, RBQM, CAPA management, protocol deviation management, and inspection readiness including BIMO preparation
- Demonstrated experience building and operationalizing risk and issue management frameworks at the portfolio or program level at a sponsor company
- Strong vendor and CRO oversight experience including governance model design, KPI development, and performance management across a complex supplier landscape
- Proven ability to influence without direct authority across a complex matrix organization spanning Clinical Operations, Quality Assurance, Regulatory Affairs, and Data Management
- Experience in biotech or pharmaceutical industry including CRO partnerships, R&D outsourcing, and supplier quality management
- Prior experience leading a team with direct line management responsibility
- Excellent analytical, communication, and presentation skills with the ability to communicate compliance trends and risks clearly to senior and executive leadership
Why This Opportunity
Our client offers a highly competitive compensation package including a base salary range of $300,000 to $310,000, target annual bonus, significant new hire equity vesting over four years, generous 401K match, and comprehensive benefits. Full relocation assistance is provided for candidates. The campus features a reliable shuttle service, a guaranteed ride home program, and flexibility for working parents and commuters.
This position is located onsite five days a week at a beautiful campus overlooking the San Francisco Bay.
