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 Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations.
Primary Responsibilities
- Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
- Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
- Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
- Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
- Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
- Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
- Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
- Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
- Other duties as assigned
Education and Experience
- Bachelor’s degree in a Life Sciences or related field. An equivalent combination of education and applicable job experience may be considered.
- Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
- Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
- American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus.
Key Skills:
- In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
- Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
- Strong ability to interpret and apply U.S. and international cGMP requirements
- Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
- Ability to translate quality standards into practical implementation and review activities
- Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
- Strong collaboration skills with the ability to influence and gain cooperation across functions
- 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.
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.
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What We Do
Our Acadia family of care-ageous warriors aspire to enable brighter moments for patients and their loved ones. For 30 years, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. Important Notice for Candidates - Be Aware of Fraudulent Recruiting Activity Acadia Pharmaceuticals has become aware of fraudulent recruiting activity being circulated via email and LinkedIn by individuals impersonating Acadia Talent Acquisition employees. These communications may appear legitimate due to an official-looking Acadia email address or website, referencing of an actual recruiter and/or manager at Acadia (easily found on LinkedIn), and/or offer documents falsely signed by an Acadia executive. The impostor uses the incentive of a job interview and job offer to solicit sensitive personal information from the intended victim. Please note that the Acadia Talent Acquisition and HR Team will ONLY interact with a candidate from "Acadia-pharm.com" domain sourced emails. We do not request sensitive personal information, such as a Social Security Number, or payments of any kind during the interview or job offer process. Acadia strongly recommends individuals, who receive email solicitations, to carefully verify the authenticity of the correspondence before responding. Never provide personal information or click on links if you are unsure a communication’s legitimacy. If in doubt, please contact [email protected] to verify.
