Sr. Manager Quality Audit and Compliance at Acadia Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

184500.0

Posted On

23 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, GMP Regulations, GxP Compliance, Internal Audits, Supplier Audits, Manufacturing Site Inspections, Collaboration Skills, Communication Skills, Regulatory Compliance, Quality Agreements, Continuous Improvement, SOP Development, Data Analysis, Technical Presentation, Quality System Optimization, Audit Readiness

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 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. Salary Range $147,600—$184,500 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 Senior Manager, Quality Audits is responsible for leading and executing internal and external audits to ensure compliance with GMP and GxP regulations. This role also involves maintaining quality agreements and supporting the effectiveness of Acadia’s Quality Management System.