Director of Quality Assurance

Prometheus Biosciences' Director of Quality will be responsible for the development, implementation, and management of Prometheus Biosciences' quality systems and operations for its drugs and in vitro diagnostics ensuring compliance with GCP, GDocP, GMP, and GLP.

The position is based at Prometheus Biosciences' site in San Diego, CA, and reports to the VP of Regulatory Affairs and Quality Assurance.

Specific responsibilities include:

• Represent Quality on project teams and oversight of quality at Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO)
• Establish, implement, and maintain phase-appropriate GxP Quality system and operations covering deviation management, investigations, CAPA, change control, and compliance programs
• Develop and maintain documentation supporting Quality system (e.g. quality manual, SOPs, and controlled documents)
• Establish and implement internal GxP compliance training programs
• Manage internal and CRO/CMO audits, working with audit vendors, maintaining audit logs, and ensuring follow-up and satisfactory closure of audit findings
• Oversee Prometheus Biosciences' R&D controlled documents, regularly reviewing the full complement to ensure appropriate scope and detail, and driving resolution of identified gaps
• Ensure appropriate Quality-focused review of clinical (e.g. protocols, study reports, IBs, ICFs, TMFs, etc.) and CMC (e.g. batch records, packaging records, disposition of drug substance and drug product, release of clinical trial materials in IRT systems) documentation
• Conduct or participate in CRO (clinical and nonclinical) and CMO qualification audits, internal and external database (e.g. clinical study and safety) audits, and key deliverables/study component (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE) audits, as appropriate
• Develop and measure Quality metrics to drive consistent standards and to facilitate regular updates to senior leadership regarding company compliance status
• Remain current with related quality legislation, compliance issues, and is an internal subject matter expert for changes in GxP expectations, including FDA, EMA, and other relevant global health authorities, guidance documents, and best industry practices
• Identify and manage appropriate contractor/vendor resources providing support for Quality initiatives
• Manage Prometheus Biosciences' electronic document system for Quality system support (e.g. for controlled documents, training management, change control)
• Scope will include in vitro diagnostic devices
• Other responsibilities at management's discretion
• Travel up to 25% of time

The employee must conduct their work activities in full compliance with defined expectations, including Prometheus Biosciences' internal requirements, GMP and ISO, and all other applicable health authority. Prometheus Biosciences internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

This document describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company's overall benefit.

Education and Experience

• Bachelor's degree minimum; advanced/graduate degree preferred
• ≥8 years experience in Quality or Quality-related roles; experience with in vitro diagnostics a plus

Essential Skills and Abilities

• A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect
• Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills
• Ability to identify and manage contract/vendor resources to support Quality-related goals
• Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors
• Strong problem and conflict resolution skills
• Exceptional business acumen, analytical skills
• Ability to develop, and manage expenditures in accordance with budget
• Travel up to 25% of time