June 2nd, 2022 Quality Assurance - GMP

Associate Director Quality Operations

San Diego, California, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Position Summary:

This role is responsible for operations of the Quality Assurance department at ACADIA, 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! Monitors manufacturing, development, and quality processes to ensure conformance to ACADIA Standard Operating Procedures (SOPs) and Quality Agreements with CMOs, as well as compliance to FDA and applicable international regulations. Expert-level user and participant in continuous improvement activities with respect to ACADIA GMP training program, change management, validation activities, batch review and release, complaint handling, Annual Product Review and CPV, CAPA program, GMP audits, and similar.

Primary Responsibilities:

  • Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement.
  • Runs and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations.
  • Leads the batch disposition process for all ACADIA drug product and substance production.
  • Leads or participates in formal risk assessment activities as required.
  • Provides on-site quality support at CMOs as required
  • Participates in 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 as needed.
  • Participates in the review of, and ensures conformance to, Quality Agreements with GMP contract service providers for outsourced operations.
  • Provides mentorship 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; may provide direction to other QA representatives on these teams.
  • Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect.
  • Participates in and/or leads Quality Operations functions, such as: Material Review Board, quality board, creative planning efforts, etc., as required by ACADIA Management.
  • Develops and/or supplies metrics to support product and/or process review efforts as needed.
  • Develops department goals and objectives for senior management review in alignment with Acadia initiatives.
  • Other duties as assigned/required.

Education/Experience/Skills:

  • Bachelor’s degree in Chemistry/Biology or related life science required.
  • A desired 7 years of related experience dynamically responsible experience within the pharmaceutical or biopharmaceutical industry with 4 years in a leadership role.
  • Experience in a Quality Assurance role is strongly preferred. Professional certifications from the American Society for Quality (ASQ), or equivalent, are a 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.
  • Demonstrated proficiency in interpretations of cGMP regulations, both US and international.
  • Skilled at efficiently 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.
  • Strong focus on flexibility, ability to multi-task, attention to detail, excellent interpersonal skills, good follow-up and judgment and ability to prioritize.
  • Efficiently leading a coordinated team effort and organizing resources to achieve team goals.
  • Able to make and prioritize process and resource decisions based on overall team needs.
  • Travel 15-20% will be required.

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. Employee must occasionally lift and/or move up to 15 pounds.

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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.