Associate Director of QMS and Vendor Management Quality

The company is a compelling, fast-growing, clinical-stage biopharmaceutical company focused on transforming metabolic disorders through innovative therapeutics.

With expanding clinical development efforts, we are seeking an experienced Associate Director of QMS and Vendor Management Quality to join the team and help ensure the highest standards of quality across our clinical programs, reporting to the Head of Clinical and non-CMC Quality.

This will be a hybrid position, with a minimum of two days per week in the office. This position may require domestic and international travel up to 25%.

The Associate Director of QMS and Vendor Management Quality, under the direction of the Head of Clinical and non-CMC Quality, will be responsible for effectively supporting GXP compliance; developing, implementing, and continuously improving our Quality Management System (QMS), overseeing the vendor management program, and GxP IT compliance.

This role ensures adherence to the global regulations across clinical, nonclinical, and CMC activities and oversees the company's QMS, vendor management, and GxP computerized systems. This will include, but not be limited to:

• Procedures development, review and approval
• Management and review of quality documentation, quality events/deviations and issue resolution, CAPAs and investigations
• Change control management
• Inspection readiness
• Audits and inspections
• Product complaints
• Conduct and oversee risk assessments
• Regulatory compliance, and effective quality oversight of internal functions and external vendors throughout the product lifecycle.

The ideal candidate brings a strong background in Quality within a small or start-up biotech environment and is comfortable operating in a dynamic, fast-paced and hands-on role. The ideal candidate has an energetic, engaging, and agile personality; we are looking for a quality-oriented, proactive achiever with high integrity.

Quality Systems Management

• Lead development, implementation, maintenance, and continuous improvement of the QMS in alignment with FDA, ICH, EMA, and other applicable global regulations.
• Establish and maintain core quality systems, including Deviation, CAPA, and Investigation Management, Change Control, Risk Management, and Audit and Inspection Management systems.
• Ensure QMS scalability to support IND, Phase 1/3, and future commercialisation activities
• Design, implementation, administration, and continuous improvement of the Document Management System (DMS) and/or electronic Quality Management System (eQMS)
• Work closely with Clinical Operations, Clinical Development, Non-Clinical, IT, Regulatory Affairs, Pharmacovigilance, and Quality teams to identify, assess, and resolve quality issues.
• Collaborate cross-functionally to promote a culture of quality and compliance
• Author, review, and approve SOPs and quality documents in collaboration with functional stakeholders.
• Ensure inspection readiness and support regulatory inspections.
• Manage quality metrics and lead governance forums.
• Own the vendor qualification and oversight process.
• Schedule, lead/perform audits, performance reviews, and vendor lifecycle oversight, as needed.
• Ensure appropriate QA provisions in contracts and Quality Agreements, as needed.

• Oversee validation and lifecycle management of GxP systems.
• Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+.
• Conduct IT vendor audits and system reviews.

• Provide QA support across clinical, nonclinical, and CMC.
• Review applicable to functional operations deviations, CAPAs, investigations, and change controls.
• Support inspection readiness.

Education and Experience Requirements

• Bachelor’s degree in Life Sciences required; advanced degree preferred.
• 8+ years of GxP QA experience.
• 3+ years of vendor management and audit experience.
• Experience with computerized systems validation.
• Knowledge of FDA, EMA, MHRA, TGA, ICH, and 21 CFR Part 11.

• Excellent oral and written communication, collaboration, and auditing skills are desired.
• High attention to detail, excellent organisational skills, and the ability to work on multiple projects with tight deadlines are desired.
• Experience communicating with both domestic and international collaborators with an awareness of cultural diversity.
• Ability to build scalable programs.
• Previous participation in regulatory agency inspections is preferred.
• Experience in small or start-up biotech environments is preferred.

If you are interested in having the opportunity to work with a passionate, innovative, and mission-driven team, and be emboldened to meaningfully impact this nimble, high-growth company, then this may be the opportunity for you!

Please note - the onsite requirement in San Francisco is non-negotiable, and we cannot support any costs for candidates wishing to relocate.