Job Description

Department: Quality Assurance

Reporting Manager Sr Manager, Quality Assurance

Summary of the Role:

QA Manager to support a full range of Quality Assurance functions for Oncology studies. This individual will manage and develop the Quality Management System which includes GCP oversight, controlled document management, records management, training, and vendor management.

This individual must have the ability to work independently and collaboratively in a fast-paced, team-oriented, start-up environment. The successful candidate will interact with cross-functional study teams and functional management.

General duties and essential responsibilities

• Design, implement and maintain compliance the Quality Systems (SOPs, change management, deviation management, investigation/CAPA, training, risk and vendor management).
• Liaise across departments to proactively identify opportunities to streamline and strengthen GCP processes
• and act as the QA point person on cross-functional clinical study teams
• Author, review, and approve GXP SOPs, work instructions, and any other controlled documents in collaboration with key clinical development functions and stakeholders.
• Assist in tasks related to vendor qualification and support internal compliance initiatives
• Oversee training program for all GXP personnel involved with clinical development programs; identify areas for continuous improvement and adoption of industry best practices.
• Oversee GCP activities, including internal or external audit observations, development, and management of CAPA
• Conduct training sessions for staff, as needed

Skills/Competencies required for this role:

• A. or B.S. in a scientific discipline and 5 years of direct personnel management , experience in biotech quality assurance and compliance
• Candidates with GCP experience supporting all phases of clinical trials are highly preferred
• Any previous experience in working for Oncology studies is a plus
• Demonstrated in-depth experience of implementing and managing quality systems.
• Experience with electronic Quality Management Systems and eTMFs systems preferred
• Strong and demonstrated understanding of U.S. Code of Federal Regulations, European regulations, and any other relevant global GXP regulations.
• This can be a remote position, there may be travel once or twice a year to the San Francisco office.