June 5th, 2023 Quality Assurance - GMP

Senior Manager Quality Assurance Operations

San Diego, California, United States

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The Senior Manager of Quality Assurance Operations will support the Quality Assurance department including oversight of cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP operations performed at Acadia, for all products intended for commercial and clinical (where required) use.  Primary responsibilities include batch record review and batch disposition, support of Product Complaints, Annual Product Review, Continuous Process Verification (CPV), ensuring conformance to Acadia Standard Operating Procedures (SOPs) and Quality Agreements with CMOs, as well as compliance with FDA and applicable international regulations.  Participate in continuous improvement activities with respect to Acadia GMP training program, change management, deviation investigations, CAPA program, GMP audits, and similar related activities.

Primary Responsibilities

  • Manages the batch disposition process for all Acadia drug product and substance production
  • May serve as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement
  • Leads or participates in formal risk assessment activities
  • Provides on-site quality support at CMOs as required
  • Participates in the design, implementation and management of the Acadia GMP quality management system, based on FDA and applicable international regulations
  • Ensures compliance of the Acadia GMP quality management system with FDA and applicable international quality management system regulations
  • Participates in GMP supplier audits and Acadia documentation control systems
  • Participates in the review of, and ensures conformance to, Quality Agreements with GMP contract service providers for outsourced operations
  • Provides guidance to SMEs and acts as QA lead on investigations, change management and batch record review, and establishing effective CAPA plans
  • Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards
  • Ensures adequate QA representation on all GMP commercial manufacturing, supply chain, and product development teams
  • Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect
  • Participates in Quality Operations functions, such as: Material Review Board, quality board, strategic efforts, etc., as required by Acadia Management
  • Develops and/or contributes metrics to support product and/or process review efforts as needed.
  • Other duties as assigned/required

Education and Experience

  • Bachelor’s degree in Chemistry, Biology or related life science required. Equivalent combination of relevant education and applicable job experience may be considered 
  • Targeting 8 years in a Quality Assurance role  with progressively responsible experience within the pharmaceutical or biopharmaceutical industry. Professional certifications from the American Society for Quality (ASQ) a strong plus
  • Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and FDA/EU GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer
  • Ability to lead a cross-functional team to develop solutions to a complex problem or advance a continuous improvement or preventive action opportunity
  • Experience implementing and managing quality management systems
  • Demonstrated proficiency in interpretations of cGMP regulations, both US and international
  • Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines
  • Experience conducting internal and supplier audits and manufacturing facility inspections
  • Ability to interpret and relate Quality standards for implementation and review
  • Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals
  • Able to make and prioritize process and resource decisions based on overall team and organizational needs
  • Ability to travel 20%

Physical 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 20 pounds.   Ability to travel independently overnight up to 20% of the time and work after hours if required by travel schedule or business issues.

The salary range for this role is $112,000.00 to $140,400. Actual amounts will vary depending on experience, performance, and location. 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.

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What we offer you:

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 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
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement: Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.