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About the Role
The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across Acadia's clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. This role provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and acts as a subject matter expert on GCP compliance.
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
Requirements
- 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
Skills
- GCP audit activities
- GCP quality systems
- Audit programs
- Inspection readiness
- GCP compliance
- ICH-GCP guidelines
- FDA regulations
- EU regulations
- International GCP regulations
- Auditing CROs
- Auditing investigator sites
- Auditing vendors
- Quality Agreements
- SOP development
- Quality document maintenance
- GCP audit metrics
- Compliance reporting
- Continuous improvement
- Regulatory inspections
- GCP compliance guidance
- Quality systems improvement
- Process improvement
- Procedure improvement
Location
- Remote
Work Type
- Hybrid
- Full-time
Experience Level
- Director
- 10+ years of experience
- 5+ years of direct experience in GCP Quality Assurance
Education Level
- Bachelor's degree in Life Sciences or a related scientific discipline
Salary/Compensations
- $165,900—$207,400 USD
Benefits
- Discretionary bonus
- Equity awards
- Medical insurance
- Dental insurance
- Vision insurance
- Employer-paid life insurance
- Employer-paid disability insurance
- Employer-paid business travel insurance
- Employer-paid 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
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
About the Company
- Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world.
- Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.
- We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
- At Acadia, we’re here to be their difference.
Equal Opportunity
- 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 talentacquisition@acadia-pharm.com 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.