Title: Director, Clinical Quality Assurance
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
The Director, Clinical Quality Assurance (QA) is a key expert responsible for overseeing and implementing Good Clinical Practice (GCP) QA at Forty Seven, Inc. (FSI), a clinical stage immuno-oncology biotechnology company. This responsibility includes the development, execution and maintenance of risk-based audit strategies focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and clinical trial protocols. This function will report to the Head of Regulatory Affairs.
These may include, but are not limited to, the following; other duties may be assigned
- Accountable for driving and overseeing the GCP QA and compliance activities at Forty Seven, Inc (FSI).
- Co-lead, oversee, and implement the FSI Quality and Inspection Readiness Team activities
- Ensure policies and/or procedures within clinical research, such as Clinical Development, Clinical Operations, Biostatistics, Pharmacology, Translational Medicine, Safety/Pharmacovigilance, and other departments, are adequate to achieve the goal of building quality clinical research programs with a focus on a risk-based approach
- Provide Clinical QA oversight of all relevant external vendors, including study sites and CROs, to ensure adherence to applicable regulations and guidelines in support of FSI clinical programs
- Develop, implement and monitor long-range strategic Clinical QA/Compliance plans for FSI clinical programs
- Develop internal and external GCP audit strategy; plan, conduct, and file audit reports on external vendors including CROs and study sites
- Provide expert input, evaluation, and assessments to identify Clinical QA/compliance issues as they occur
- Perform detailed review of clinical trial protocols, regulatory submissions, internal deviations, corrective action and preventive actions (CAPAs) and other essential documents prior to their Quality Assurance acceptance or approval.
- Devise and implement interventions, escalations, and CAPAs for Clinical QA/compliance issues
- Direct the development of adequate and appropriate responses and resolutions to identified audit and inspection observations and to drive timely completion of the agreed corrective and preventive actions.
- Work with CROs and consultants as necessary to maintain high Clinical QA/Compliance standards across the organization; Identify, communicate, and escalate GCP/GLP/GVP risk and serious non-compliance situations and follow to resolution, acting at all times with an appropriate sense of urgency.
- Form strategic partnerships with other Functional Area Heads (e.g. Core Team Leaders, Project Management, Clinical Development, Biometry, Clinical Data Management, GMP Quality Assurance, Regulatory, Clinical Pharmacology, Pharmacovigilance, and Research) and other functions to ensure the delivery of high quality clinical data
- Accountable for establishing and monitoring QA/Compliance standards and metrics across the clinical development portfolio
- Ensure that clinical activities are conducted with high quality and in compliance with cGCP, cGLP, and cGVP standards and that adherence to company and/or CRO SOPs, FDA/EMA regulations, ICH GCP guidance, and study protocols are maintained such that FSI is inspection ready at all times; support clinical programs to ensure study-specific inspection preparedness
- Identify and resolve any gaps in company/CRO SOPs, policies, procedures, and work instructions and develop internal SOPs as needed.
The Director of Clinical QA is a senior leader for the company, this individual must excel at management and group leadership.
- Plan for the future growth of a Clinical QA team as dictated by the needs of the company over time
- Communicate risk information to upper management in an appropriate manner
- Accountable for the creation and management of Clinical QA functional budget
- Embrace and serve as a role model for the FSI culture to help create a nurturing and high functioning team
- Lead or participate in company-wide initiatives to support and influence the future direction of the organization
Education & Experience:
- A minimum of 12 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent and with at least 8 years in quality or compliance.
- Extensive experience in GCP auditing and managing regulatory authority inspections.
- Minimum of 6 years direct management experience
- Bachelor’s or Master’s degree in a scientific or life sciences discipline. A healthcare background is preferred.
- A strong work ethic and ability to work independently and productively.
- Sustained record of outstanding performance and accomplishments in drug development with in-depth knowledge and application of international requirements of Good Clinical Practice (GCP), ICH GCP Guidelines, GLP, GVP regulations and compliance initiatives globally applicable to the conduct of clinical trials
- Strong skills in communicating across multiple functional areas with a focus on problem solving and real-world solutions
- Exemplary interpersonal engagement and cross-functional partnering/collaboration skills.
- Strong potential for executive leadership presence and confidence in challenging peers and senior management at all levels
- Strong stakeholder management skills that can proactively influence other functional areas to positively impact their contributions to QA and compliance
- Dedication to sustaining diversity and inclusion in the workplace
- Ability to flex and adapt in a fast-pace, dynamic, and high-pressure environment while sustaining progress, focus, and high morale in the face of uncertainty or ambiguity
- Possess a passion for action combined with an inquisitive scientific mindset, while simultaneously being humble, yet bold
- A commitment to nimble execution in the development of transformation therapies that can help patients defeat their cancer
- Ability to work onsite in Menlo Park, CA at the Forty Seven, Inc. offices
- Willingness to travel up to 25% of the time
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international.