Position Summary
Primary Responsibilities
- Plan, schedule, coordinate, and conduct GMP compliance audits of Contract Service Providers (CSPs), suppliers, and internal operations in accordance with company standards and applicable domestic and international regulations
- Prepare and review audit reports, evaluate observations and corrective actions, and ensure identified compliance issues are appropriately addressed
- Oversee the development, negotiation, approval, and maintenance of Quality Agreements with clinical and commercial CSPs
- Maintain the internal audit program and compile audit metrics and compliance trends to support Management Review and quality system oversight
- Prepare, review, and maintain Standard Operating Procedures (SOPs) and support continuous improvement of quality systems in accordance with current GMP requirements and industry standards
- Provide compliance expertise across GxP activities, including annual product reviews, mock recalls, field alerts, actual recalls, and quality system-related computerized solutions
- Ensure quality systems, procedures, and processes comply with applicable FDA, EU/EudraLex, Canadian, ICH, and other international GMP requirements
- Provide Computer System Validation (CSV) support for quality system-related computerized solutions, as needed
- Recommend and implement updates to quality policies and procedures based on evolving regulations, compliance trends, and business requirements
- Perform other duties as assigned
Education and Experience
- Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of relevant education and experience
- Minimum of 6 years of progressively responsible Quality Assurance experience, including at least 3 years of direct GMP Quality Assurance experience
- Experience conducting external/supplier and internal GMP audits, including audits or inspections of manufacturing facilities
- Working knowledge of U.S. and international GMP regulations and quality requirements, including applicable FDA, EU/EudraLex, and ICH requirements
- Experience applying GMP requirements across relevant pharmaceutical or biopharmaceutical operations, including clinical development, manufacturing, technology transfer, and/or commercial activities
Phycical 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.
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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.
Skills Required
- Bachelor's degree in Life Sciences or a related field, or equivalent relevant education and experience
- At least 6 years of progressively responsible Quality Assurance experience
- At least 3 years of direct GMP Quality Assurance experience
- Experience conducting external or supplier and internal GMP audits, including manufacturing facility audits or inspections
- Working knowledge of U.S. and international GMP regulations, including FDA, EU/EudraLex, and ICH requirements
- Experience applying GMP requirements across pharmaceutical or biopharmaceutical operations, including clinical development, manufacturing, technology transfer, or commercial activities
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.
