Director, GCP Quality Assurance
acadiapharmaceuticals · Princeton, New Jersey, United States; San Diego, California, United States; South San Francisco, California, United States ·
- Employment
- Contract
- Category
- QA
- Experience
- 5+ years
- Salary
- USD 165,900 – 207,400 / year
Director-level Quality Assurance role leading Good Clinical Practice (GCP) audit activities across Acadia's clinical development portfolio — conducting internal/external audits of CROs, investigator sites, and vendors, maintaining GCP quality systems and SOPs, and supporting FDA/ICH regulatory inspection readiness. Requires deep pharma/biotech GCP QA and lead auditing experience.
Position Summary
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.
#LI-Hybrid
#LI-CS1
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.
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.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.