Sr. Manager Quality Audit and Compliance

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Hybrid; USD 138.000 - 172.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

401(k) plan with company match

Equity awards

Paid time off

Zusammenfassung

Acadia Pharmaceuticals Inc. is seeking a Sr. Manager, Quality Assurance Compliance to lead GMP audit activities for CSPs and internal operations while upholding global regulatory standards.

You will manage Quality Agreements, drive continuous improvement across GxP systems, and provide expert QA compliance guidance for FDA, EU, ICH, and other requirements. A hybrid work setup is available from Princeton or San Diego.

Qualifikationen

• Bachelor’s degree in Life Sciences or equivalent experience.
• Minimum 6 years in Quality Assurance with at least 3 years GMP QA.
• Experience conducting external/internal GMP audits of facilities.

Aufgaben

• Plan, schedule, and conduct GMP audits of CSPs, suppliers, and internal ops.
• Prepare audit reports, evaluate observations, and track corrective actions.
• Maintain Quality Agreements with CSPs and internal teams.
• Oversee internal audit program and compile metrics for reviews.
• Draft and maintain SOPs; support continuous improvement of quality systems.
• Provide QA compliance expertise across GxP activities and recalls as needed.
• Ensure compliance with FDA, EU/EudraLex, ICH, and other GMP requirements.
• Provide CSV support for quality system software as needed.

Kenntnisse

GMP audits

Quality Systems

Audit management

Regulatory compliance

CSV support

Ausbildung

Bachelor's degree in Life Sciences

Tools

Audit management software

CSV tools

Jobbeschreibung

This is a hybrid role requiring three days per week onsite and may be based in either our San Diego, CA or Princeton, NJ office

Position Summary

The Sr. Manager, Quality Assurance Compliance will play a key role in supporting Acadia’s growing portfolio by leading internal and external GMP audit activities and maintaining robust quality systems. This position is responsible for ensuring Contract Service Providers (CSPs) and internal operations meet Acadia standards and applicable U.S. and international regulatory requirements, while overseeing Quality Agreements and supporting continuous improvement across GxP operations.

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.

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

$138,000 — $172,100 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 [e-mail] 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.

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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.