Director, GCP Quality Assurance

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Sur place; USD 166 000 - 207 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

Healthcare: Medical, dental, vision

Employer-paid life, disability, travel

401(k) with match

Employee Stock Purchase Plan

Vacation days: 15+

Paid holidays: 13-15

Paid sick time: 10 days

Parental leave

Tuition assistance

Résumé du poste

ACADIA Pharmaceuticals Inc. in Princeton, NJ, seeks a Director, GCP Quality Assurance to lead audit activities across our clinical development portfolio and ensure compliance with FDA, ICH-GCP, EU regulations.

You will manage internal and external audits, develop quality agreements, SOPs, and maintain audit metrics to support inspection readiness and continuous improvement. Requires a Bachelor's in Life Sciences, 10+ years in pharma/biotech, 5+ years in GCP QA with Lead Auditor experience; SQA

Qualifications

• 10+ years of experience in the pharmaceutical/biotech regulated industry.
• 5+ years of direct experience in GCP Quality Assurance and auditing.
• Lead Auditor experience for internal and external GCP audits.
• Strong knowledge of ICH-GCP, FDA, EU, and international GCP regulations.
• Experience auditing CROs, investigator sites, vendors, and GCP service providers.
• Experience supporting regulatory inspections and inspection readiness.

Responsabilités

• Plan, schedule, conduct, and manage internal and external GCP audits of CSPs, CROs, investigator sites, and supporting vendors to ensure compliance with company standards and global GCP regulations
• Prepare, review, and finalize audit reports, ensuring observations, risks, and corrective actions are documented and appropriately tracked to resolution
• Lead the development, review, and maintenance of GCP Quality Agreements with CROs, CSPs, and other clinical study partners
• Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement initiatives
• Develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities
• Manage the internal GCP audit program, including audit planning, execution, follow-up activities, and effectiveness assessments
• Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems
• Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements
• Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness
• Other duties as assigned

Connaissances

GCP Quality Assurance

Lead Auditor

Audit Management

FDA/ICH/GCP regulations

CRO/Vendor Audits

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

Position Summary

The Director, GCP Quality Assurance is responsible for leading Good Clinical Practice (GCP) audit activities across Acadia's clinical development portfolio to ensure compliance with applicable global regulatory requirements and internal quality standards. This role provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness initiatives, and serves as a subject matter expert on GCP compliance.

Primary Responsibilities

• Plan, schedule, conduct, and manage internal and external GCP audits of Contract Service Providers (CSPs), CROs, investigator sites, and supporting vendors to ensure compliance with company standards and global GCP regulations
• Prepare, review, and finalize audit reports, ensuring observations, risks, and corrective actions are documented and appropriately tracked to resolution
• Lead the development, review, and maintenance of GCP Quality Agreements with CROs, CSPs, and other clinical study partners
• Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement initiatives
• Develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities
• Manage the internal GCP audit program, including audit planning, execution, follow-up activities, and effectiveness assessments
• Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems
• Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements
• Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness
• Other duties as assigned

Education and Experience

• Bachelor's degree in Life Sciences or a related scientific discipline, or an equivalent combination of education and relevant experience
• 10+ years of experience within the pharmaceutical, biotechnology, or related regulated industry
• 5+ years of direct experience in GCP Quality Assurance, compliance, and auditing functions
• Demonstrated experience serving as a Lead Auditor for internal and external GCP audits
• Strong knowledge of ICH-GCP guidelines and applicable FDA, EU, and international GCP regulations
• Experience auditing CROs, investigator sites, vendors, and other GCP service providers
• Experience supporting regulatory inspections and inspection readiness activities
• Ability to interpret and apply global GCP regulations to quality systems and clinical trial operations

Preferred Qualifications

• SQA, ASQ, or Lead Auditor certification
• Experience conducting global audits across US, EU, UK, Japan, and other international regions
• Experience with clinical service providers and supporting functions such as eCOA, computerized system validation (CSV), and data management

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule and/or business priorities.

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$165,900—$207,400 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

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