Senior Director, Quality

---

Job description

Senior Director of Quality

The Position:

Bolt Biotherapeutics has an exciting opportunity for an experienced Quality leader to build and lead our Quality organization. You will be responsible for the strategic development and execution of the Company's quality programs and administration of the GxP Quality Systems ensuring GMP, GCP, and GLP compliance in accordance with US and global regulations. You will build a team of internal staff, consultants and contractors as required to address all global Quality matters, addressing both Quality Control and Quality Assurance. This position requires expertise in current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) as well as relevant regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement. The candidate will develop internal processes to ensure compliance with all relevant oversight and regulations.

Responsibilities

• Ensures that the GxP Quality System meets standards expected by US and global health authorities for preclinical research, clinical development, and commercial operations.
• Maintains and continually improves Quality governance practices to meet business and compliance needs
• Provides Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical activities. Determines applicable quality standards and regulations and ensures ongoing compliance
• Establishes strong working relationships with external manufacturers and vendors and assures alignment of Quality Systems, negotiating quality agreements and communication of Bolt requirements to providers.
• Develops strong collaborative relations across functions (i.e., clinical, operations, manufacturing) to ensure alignment and compliance.
• Establishes, maintains, and has oversight of internal Quality Management Systems.
• Ensures appropriate quality criteria are built into selection, implementation or upgrading of electronic systems used to support any GxP related activities

Provides risk-based, phase appropriate Quality oversight of external vendors (CMOs, CROs, etc.)

• Provides leadership and mentorship of the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
• Keeps abreast of industry developments, forthcoming regulations, guidance, best practices etc.
• Counsels, trains and interprets quality requirements to ensure we and our GxP vendors maintain a state of compliance.
• Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management. Partners with teams in development of mitigation strategies.
• Serves as primary contact in any audit by regulatory authorities and leads all audit communications with audit personnel.
• Responsible for supplier/vendor risk management, qualification audit and inspection management program, including clinical and manufacturing audits.

Requirements

• 15+ years of relevant experience in the pharmaceutical or biotechnology industry
• BS Degree in a scientific discipline. Advanced degree preferred.
• Proficient experience in managing Quality Systems/SOPs
• Experience in global corporations as well as small innovator companies preferred
• Experienced in building a quality organization, developing staff and defining quality strategy
• Exceptional organizational skills with the ability to prioritize work, manage against deadlines, maintain focus, and monitor progress on assigned tasks
• A creative, collaborative approach to developing and implementing processes
• Excellent written and verbal communication and presentation skills
• Occasional travel is required for vendor management meetings
• Broad experience with GxP operations and in-depth knowledge of pharmaceutical product development
• Ability to work independently, and cross-functionally, and develop/maintain strong partner relationships, both internal and externally.

Who We Are:

Bolt Biotherapeutics, based in the San Francisco Bay Area, is a publicly traded clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors followingsystemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity tojoin and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers. We are an Equal Opportunity Employer offering a competitive salary and benefits package.

<!– job description page –>