Associate Director, GLPGCP Quality Audits and Compliance

Please note that this position can be based in San Diego CA OR Princeton NJ OR San Francisco CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director GLP/GCP Quality Audits and Complianceplays a critical role in protecting data integrity and regulatory readiness across the companys nonclinical and clinical portfolio. This position leads the planning execution and reporting of internal and external GLP/GCP audits ensuring compliance with U.S. and international regulations while driving continuous improvement in quality systems.

As a trusted quality partner this role provides expert guidance on GLP/GCP compliance supports regulatory inspections and works closely with internal teams and Contract Service Providers (CSPs) to maintain inspection-ready operations. The ideal candidate brings strong audit leadership sound regulatory judgment and the confidence to influence quality practices across the organization.

Primary Responsibilities

• Plan schedule coordinate and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs) in accordance with company standards and global regulatory requirements
• Own the end-to-end audit lifecycle including audit preparation execution documentation reporting follow-up and verification of corrective and preventive actions
• Prepare review and approve clear compliant audit reports ensuring observations risks and responses are accurately documented and resolved
• Develop review and maintain GLP/GCP quality agreements SOPs and related quality documentation supporting nonclinical and clinical activities
• Maintain manage and continuously improve the internal GLP/GCP audit program ensuring ongoing inspection readiness
• Compile analyze and trend audit metrics to support management review quality oversight and regulatory inspections
• Serve as a GLP/GCP subject matter expert partnering with internal and external stakeholders (e.g. laboratory leadership study directors regulatory affairs CSPs) to ensure consistent regulatory compliance
• Support internal audits mock inspections and regulatory inspections recommend policy and process improvements with company-wide impact and ensure adherence to company policies including Privacy/HIPAA and other applicable legal and regulatory requirements
• Other duties as assigned

Education and Experience

• Bachelors degree in Life Sciences or a related scientific/technical discipline. An equivalent combination of education and applicable job experience may be considered
• Targeting 8 years of progressively responsible experience within quality assurance (QA) including 5 years directly responsible for GLP/GCP QA with direct experience leading external and internal audits
• Extensive knowledge of guidelines and international regulations that affect the GLP/GCP QA programs
• Society for Quality Assurance (SQA) American Society for Quality (ASQ) or ECA academy certification and/or European Lead Auditor experience is a plus

Key Skills:

• Thorough knowledge of quality management best practices within the pharmaceutical biopharmaceutical or other regulated industries
• Demonstrated expertise in quality assurance activities and ICH FDA EU and international GLP/GCP regulations as they apply to nonclinical and clinical studies
• Proven ability to interpret and apply GLP/GCP regulations including U.S. and global requirements
• Hands-on experience conducting internal audits supplier audits and inspections of laboratories clinical operations and manufacturing facilities
• Strong capability to translate quality standards into practical implementation assess compliance and drive continuous process improvement
• Effective communicator able to present technical and regulatory information clearly across functions and to different stakeholder groups
• Ability to create alignment and shared understanding among peers and stakeholders effectively coordinating resources and motivating teams to achieve quality objectives
• Demonstrated analytical planning and negotiation skills with sound judgment in evaluating risk and compliance impact
• Collaborative approach with a proven ability to gain cooperation and influence outcomes without direct authority
• Willingness to travel domestically and internationally (approximately 2530%)

Scope

Manages department section to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. It will require a focus on issues of moderate to diverse scope which will require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-Hybrid #LI-SL1

Required Experience:

Director