Associate Director Quality Assurance

Associate Director, Quality Systems - Hybrid - 3 days per week onsite - San Fran Bay Area

We are retained with a clinical stage biotechnology company that is continuing to build its Quality organisation as its development portfolio progresses.

The company is seeking an Associate Director, Quality Systems to take a central role in developing, operating and continuously improving the Quality Management System supporting its GxP activities.

This is not intended to be a purely administrative Quality Systems position.

The successful candidate will act as a Quality partner to teams throughout the organisation, helping establish systems that are compliant, scalable and practical for a growing clinical-stage biotechnology company.

The role will work closely with Quality leadership and cross-functional partners across Clinical Development, Clinical Operations, Regulatory Affairs, CMC and Technical Operations.

Key Responsibilities

• Lead the ongoing development, implementation and continuous improvement of the company's Quality Management System.
• Act as a subject matter expert for Quality Systems and provide practical guidance to teams working across GxP activities.
• Support the implementation, administration and optimization of electronic Quality Management Systems.
• Oversee key Quality processes including:
• Document control
• SOP lifecycle management
• Training
• Deviations and investigations
• CAPA
• Change control
• Quality events
• Quality metrics and trending
• Establish scalable and phase-appropriate Quality processes capable of supporting an expanding clinical development portfolio.
• Partner with functional teams to develop and revise SOPs, policies, work instructions and controlled documentation.
• Ensure controlled documents and Quality records are appropriately created, reviewed, approved, distributed, maintained and archived.
• Help define Quality metrics and dashboards that enable leadership to identify trends, emerging risks and opportunities for continuous improvement.
• Monitor CAPA and Quality event performance, ensuring actions are appropriately investigated, documented and closed within agreed timelines.
• Provide guidance on root cause analysis and support teams in developing effective and sustainable corrective and preventive actions.
• Support the development and delivery of GxP training programs across the organisation.
• Work closely with Clinical Quality, GMP Quality and Regulatory colleagues to ensure Quality Systems appropriately support the wider GxP environment.
• Support integration and alignment between Quality systems and other regulated platforms, including electronic trial and document-management systems.
• Participate in internal audits, vendor audits and Quality-related assessments as required.
• Support regulatory inspection readiness, including preparation of Quality documentation, records and subject matter experts.
• Monitor evolving FDA, ICH and global regulatory expectations and assess their potential impact on existing Quality processes.
• Identify opportunities to simplify and improve Quality processes while maintaining an appropriate level of compliance and control.
• Help foster a culture of Quality ownership across the organisation rather than concentrating responsibility solely within the Quality function.

What We're Looking For

• Bachelor's degree in Life Sciences, Quality, a scientific discipline or a related field.
• Approximately 8–10+ years of biotechnology or pharmaceutical industry experience, with substantial experience working within GxP Quality.
• Strong hands-on experience developing, implementing or maintaining pharmaceutical Quality Management Systems.
• Experience with electronic QMS platforms; experience with systems such as Veeva Vault would be particularly useful.
• Strong knowledge of document control and controlled-document lifecycle management.
• Practical experience with CAPA, deviations, investigations, change control and Quality event management.
• Strong understanding of root cause analysis and the development of sustainable corrective actions.
• Experience developing or maintaining SOP and GxP training programs.
• Familiarity with electronic TMF or other regulated document-management environments is beneficial.
• Understanding of FDA, ICH and applicable global GxP requirements.
• Experience supporting clinical-stage biotechnology or pharmaceutical organisations is strongly preferred.
• Previous involvement in regulatory inspection readiness or regulatory inspections would be advantageous.
• Ability to translate regulatory requirements into processes that teams can realistically operate.
• Strong project-management and organisational skills with the ability to manage multiple Quality initiatives simultaneously.
• Excellent written and verbal communication skills.
• Collaborative and pragmatic approach with the confidence to challenge appropriately when Quality or compliance risks arise.
• Comfortable working in an evolving environment where systems are being built and improved rather than simply maintained.

Why Join?

This position offers the opportunity to have meaningful ownership of the Quality infrastructure of a growing clinical-stage biotechnology company.

As development programs progress and the organisation's GxP responsibilities expand, Quality Systems will become increasingly important to inspection readiness, operational consistency and the company's ability to scale.

The successful candidate will therefore have the opportunity not simply to administer an existing QMS, but to help determine how the Quality organisation operates as the company moves into its next stage of development.