Associate Director, Clinical Quality Assurance

Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.

The Position:
The Associate Director Clinical Quality Assurance (CQA) is a critical quality leader responsible for the development and implementation of a risk-based Good Clinical Practice (GCP) oversight process to support the Bolt clinical programs. A necessary element of program oversight is identification of quality risks, communicating them within the organization and working with program teams to mitigate where required.

Responsibilities include supporting the clinical study teams, assessing the effectiveness of GCP processes, conducting GCP audits, supporting the development, tracking, and trending of Quality metrics, creating and presenting actionable reports, presenting data to Senior Management, and supporting or hosting Health Authority GCP inspections.

Key Responsibilities:
Clinical Quality Assurance is responsible for the following key activities:
• Execute clinical quality projects in line with corporate strategic objectives.
• Develop and execute the Clinical Quality Management Plan in compliance with internal and industry standards, applicable regulations, and guidelines.
• Represent Quality Assurance on study teams including dissemination of key quality information, guidance and support.
• Coordinate with CRO quality to ensure sponsor-delegated responsibilities are carried out in a compliant manner.
• Write, revise and review controlled documents (e.g., SOPs, work instructions, protocols) to ensure GCP compliance with internal standards, ICH, applicable regulations and guidelines.
• Oversee GCP activities, including internal or external audit observations and adverse trends to ensure patient safety and data integrity.
• Coordinate inspection readiness based on BIMO and comparable international guidance.
• Report GCP related risks to senior management as well as plan for corrective and/or preventive actions (CAPA), when required.
• Manage and facilitate the clinical audit plan, process and improvement programs resulting from audits, quality events, discrepancies, queries and complaints.
• Support evaluation and acceptability of clinical vendors. Provide quality and compliance direction, guidance and strategy.
• Evaluate new regulations and guidelines for necessary revisions to the clinical quality program. Identify and communicate related business and regulatory risks.
• Provide support and coaching to other staff members to develop additional quality and auditing resources.
• Participate in regulatory inspections, both site (as requested), CRO (as requested) and sponsor.
• Communicate any critical compliance risks identified from these activities to the Head of QA
• Interact with partners, collaborators or other external entities
• Other tasks as assigned

Job Requirements:
• Bachelor's Degree in Life Sciences or related field plus a minimum of 10 years of related clinical quality experience
• Demonstrable understanding of Good Clinical Practice (FDA, EMA, ICH and others as applicable to the clinical programs)
• Experience with Word, Excel, PowerPoint
• Good technical writing skills and detail oriented
• Excellent written and verbal communication and collaboration skills
• Exemplary time management, prioritization and organizational skills.
• Discretion with confidential information
• Ability to work independently and on project teams to achieve goals
• Experience with IND, IMPD and marketing authorization filings desirable
• Experience collaborating with CRO’s desirable
• Some travel may be required, including domestic and international (10-20%)
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.