Manager, Quality Systems

Posted 3 Days Ago
Be an Early Applicant
3 Locations
In-Office
100K-125K Annually
Mid level
Pharmaceutical
The Role
The role manages the electronic Quality Management System, supports CAPA, Change Management, and Deviation processes, and ensures compliance with quality records.
Summary Generated by Built In
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 San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary: 

This role supports the administration, oversight, and continuous improvement of the electronic Quality Management System (eQMS), including Deviation, CAPA, and Change Management processes. The position ensures quality records are compliant, complete, and closed within established timelines while maintaining alignment with regulatory and business requirements. In addition to process support, this role provides QMS system administration, testing, reporting, and end-user guidance to ensure the quality system operates effectively and supports inspection readiness.


Primary Responsibilities:

• Provides support for the implementation and maintenance of the quality systems program.

• Assists with the oversight of the Corrective and Preventive Action (CAPA) process to ensure CAPAs and associated records are reviewed and completed in a timely and compliant manner.

 • Assists with the oversight of the Change Management program to ensure continuous compliance of the Quality System. Assist with ensuring timely completion/closure of change management records.

• Assists with the oversight of the Deviation process to ensure deviations and associated records are reviewed and completed in a timely and compliant manner.

• Provides support and training to end users for processing Deviation investigations, CAPAs and Change Management.

• Management of electronic Quality Management System (QMS) (e.g., Veeva Vault QMS), including troubleshooting issues through testing in Veeva Sandbox environment. Author, review and execution of PQ scripts within Veeva Test environment.

• Ensures quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.

• Provides support for Quality System metrics, including review and identifying/addressing trends. Provides support for internal audit and regulatory inspections of quality management systems.

• Provides QMS Business Administrator support to end users (e.g. reassigning tasks, updating picklists or objects, creating reports and dashboards.)

• Other duties as assigned.



Education/Experience/Skills:

Bachelor’s degree in Life Sciences or an equivalent combination of relevant education and applicable job experience may be considered. A minimum of 3 years Quality Systems experience.



Requirements:

• Proficiency in Microsoft Excel, Word, and Outlook.

• Critical thinking skills in analyzing and exercising judgement on complex issues, guided by a thorough understanding of quality philosophy.

• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.

• Skilled at effectively communicating department or area issues and results within and across functional areas.

• Able to gain cooperation of others.




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
$100,000$125,200 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 [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.

Top Skills

Excel
Microsoft Outlook
Microsoft Word
Veeva Vault Qms
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The Company
HQ: San Diego, California
701 Employees
Year Founded: 1993

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.

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