Associate Director, GLP/GCP Quality Audits and Compliance at Acadia Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

181500.0

Posted On

23 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GLP, GCP, Regulatory Compliance, Audit Management, Data Integrity, Continuous Improvement, Risk Assessment, Communication Skills, Analytical Skills, Planning Skills, Negotiation Skills, Collaboration, Leadership, SOP Development, Quality Management

Industry

Pharmaceutical Manufacturing

Description

About Acadia Pharmaceuticals 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. Please note that this position can be based in San Diego, CA OR Princeton, NJ OR San Francisco, CA. Acadia's 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 Compliance plays a critical role in protecting data integrity and regulatory readiness across the company’s 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 Bachelor’s 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 25–30%) 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 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 $145,200—$181,500 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. 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. 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.

Responsibilities

The Associate Director leads the planning, execution, and reporting of GLP/GCP audits, ensuring compliance with regulations. This role also involves maintaining inspection-ready operations and providing expert guidance on quality practices.