Director, GLP Quality Assurance

Bayside Solutions; California (MO); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Bayside Solutions, Inc. seeks a Director of Good Laboratory Practice Quality Assurance (GLP QA) to ensure GLP compliance across our company and external vendors contracted for regulated work.

The role emphasizes audit program development, vendor qualifications, and cross-functional collaboration with NDCP and QA teams. The successful candidate will oversee GLP audits, ensure regulatory alignment with 21 CFR Part 58/11, OECD GLP, ICH GCP, and related guidance, and manage risk-based QA activities

Qualifications

• Bachelor's or Master's Degree in a relevant field
• 12+ years of experience in global GLP QA
• Extensive audit and inspection management experience

Responsibilities

• Researches laboratory vendors that perform GLP work.
• Develops the annual vendor audit plan.
• Performs or manages vendor audits and reports.
• Maintains vendor approval status in Veeva.
• Develops/reviews Quality Agreements for GLP studies.
• Liaises with GLP vendor QA departments on deviations and CAPAs.
• Provides QA guidance for computerized systems supporting GLP studies.

Skills

GLP QA

Audit management

Regulatory compliance

Risk management

Cross-functional leadership

Education

Bachelor's degree

Master's degree

Tools

Veeva

Job description

Location:

Redwood City, CA - Hybrid Role

Job Summary:

The Director, Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at our company and external vendors contracted to perform regulated work on our behalf, including all GLP vendors.

Duties and Responsibilities:

• Responsibilities include researching laboratory vendors that perform work to support regulated clinical studies.
• Develops the annual vendor audit plan.
• The Director GLP QA performs and/or manages vendor audits, including:
• Development of the audit plan, audit conduct, and reporting
• Tracking and coordination of audit closure tasks, including review of observation responses from vendor(s) in conjunction with operational subject matter experts (SMEs), as applicable.
• Provision of vendor approval recommendations
• Maintenance of vendor approval status in Veeva.
• Development and/or review of Quality Agreements
• Performs or participates in internal audits.
• Provides QA review of CRO study protocols and reports for compliance utilizing a risk-based approach, as needed, and serves as an advisor to the Nonclinical Development and Clinical Pharmacology (NDCP) to resolve compliance issues.
• Monitors vendor QA units for compliance with applicable regulations, including review of vendor study-specific QA audit reports.
• Advises Sponsor(s) on compliance requirements for test and control articles used in GLP studies.
• Liaises and/or consults with GLP vendor QA departments on study-related issues such as deviations, investigations, CAPAs, and other compliance issues.
• Provides annual GLP training or liaises with an external trainer to provide GLP training to our functional team(s).
• Attends functional area meetings (e.g., NDCP and Biomarker group) to discuss and review new or ongoing issues, projects, and/or studies.
• Works with QA management for resource planning, as needed.
• Attends periodic clinical QA group meetings, as needed.
• Provides periodic quality and compliance updates to QA management.
• Develops/prepares standard operating procedure (SOPs) content for GLP audits, and reviews functional area and QA SOPs for GLP compliance.
• Provides consultative QA guidance for computerized system vendors (and systems) supporting GLP studies.

Requirements and Qualifications:

• Bachelor's or Master's Degree
• 12+ years of experience in global Good Laboratory Practice (GLP) Quality Assurance (QA)
• Extensive audit and inspection management experience

Preferred Qualifications

• Registered Quality Assurance Professional - Good Laboratory Practice (RQAP-GLP)
• Planning and scheduling expertise
• Experienced in effective prioritization of competing initiatives and tasks across multiple projects
• Ability to communicate effectively with senior leadership, management, and cross-functional teams
• Ability to manage workstreams to maintain delivery timelines through disciplined planning, tracking, and follow‑up
• Ability to balance detail‑oriented execution with strategic oversight
• Experienced with the proactive identification, assessment, and mitigation of risks and with timely issue escalation, as applicable
• Regulatory expertise with at least the following regulations and guidance:
• 21CFR Part 58 Good Laboratory Practice
• 21 CFR Part 11 Electronic Records; Electronic Signatures
• OECD #1 - 24 Standards and Advisory Documents on Good Laboratory Practices
• ICH E6 (R2 and R3) Good Clinical Practices
• Japanese Ministry of Health, Labor and Welfare (MHLW) - Good Laboratory Practice
• Applicable US and EU guidance documents, including bioanalytical, in vitro, and in vivo genetic, Phototox, and hERG toxicology studies
• Experience with the following audit types:
• Testing facilities
• Bioanalytical and PK data analysis Labs
• hERG and Phototoxicity testing facilities
• Archives - biorepositories, paper, and electronic data storage
• Computer Systems Validation
• Biomarker Labs (including Artificial Intelligence and Machine Learning)
• Central Laboratories

Desired Skills and Experience

GLP Quality Assurance, global GLP compliance, 21 CFR Parts 11 and 58, OECD GLP, ICH GCP, MHLW GLP, vendor qualification and oversight, vendor and internal audits, inspection management, risk-based CRO oversight, audit reporting and closure, CAPA and investigations, Quality Agreements, Veeva, SOP development, regulatory compliance, computerized systems validation, laboratory and testing facility audits, bioanalytical and PK audits, toxicology studies, biomarker and central laboratory audits, GLP training, risk management, resource planning, project prioritization, cross-functional leadership, senior management communication, RQAP-GLP preferred

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