Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Associate Director, Quality Operations

$145.1k - $181.4k

ACADIA Pharmaceuticals

Please note that this position is based in San Diego, CA or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Quality Operations plays a critical role in ensuring the quality, compliance, and integrity of Acadia’s clinical and commercial products. This role provides GMP quality oversight for both internal operations and Contract Manufacturing Organizations (CMOs) across all stages of the product lifecycle. The position partners closely with manufacturing and development teams to support reliable supply, regulatory compliance, and continuous improvement in alignment with FDA and global GMP requirements. Primary Responsibilities Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs Serve as the primary quality interface with CMOs to ensure compliance with SOPs, Quality Agreements, and regulatory expectations Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations Support complaint handling activities, including investigation and closure Support the design, implementation, and maintenance of Acadia’s GMP quality management system in compliance with US and international regulations Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required Represent Quality Assurance on cross‑functional GMP manufacturing, packaging, supply chain, and development teams Other duties as assigned Education/Experience/Skills Bachelor’s degree in Chemistry, Biology, or a related life science Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations Demonstrated experience with US FDA and international GMP regulations Experience overseeing CMOs and outsourced GMP manufacturing activities Ability to travel up to 15–20% Physical Requirements This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs. 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: $145,100–$181,400 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 View email address on click.appcast.io or View phone number on click.appcast.io. 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. #J-18808-Ljbffr

Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Quality Operations in Princeton, NJ vacancy
  • $140k - $180k

     ...As we advance our clinical pipeline, we are seeking an  Associate Director, TMF Operations to lead Trial Master File (TMF) operations across our oncology...  ..., enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process... 
    Suggested
    Full time
    3 days per week

    Systimmune

    Princeton, NJ
    18 days ago
  •  ...Research, Commercial, Cell Therapy). Supervise junior to mid-level team members to ensure effectiveness, efficiency, consistency, quality, and compliance with external regulations and internal procedures. Collaborate with cross-functional, multi-location IT Delivery teams... 
    Suggested
    For contractors

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago
  • $142.5k - $256.5k

     ...The Role The Associate Director of Operations will support Moderna’s US Commercial Operations. This role is an exciting opportunity to be a critical...  ..., product profile, NDCs), ensuring data accuracy and quality. Provide comprehensive customer support for multiple teams... 
    Suggested
    Work from home

    Initial Therapeutics, Inc.

    Princeton, NJ
    5 days ago
  • $175k - $190k

     ...California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across... 
    Suggested
    Summer work
    Local area

    Kyowa Kirin North America

    Princeton, NJ
    2 days ago
  •  ...Dormont Manufacturing Co is seeking an Associate Director of Operations to manage commercial operations supporting strategic customers in Princeton, NJ. This role encompasses overseeing order management processes, customer relationships, and cross-functional collaboration... 
    Suggested

    Dormont Manufacturing Company

    Princeton, NJ
    4 days ago
  • $120k - $230k

     ...Overview Technology Associate Director – Marketing & Operations (North America – Generics, Biosimilar & Market Access) supports the Global Commercial Technology function and regional commercial and marketing teams in Sandoz. Location Princeton, NJ, United States (Hybrid... 
    Local area
    Remote work
    Relocation package
    Flexible hours

    U023 (FCRS = US023) Sandoz Inc

    Princeton, NJ
    5 days ago
  •  ...Technology Associate Director Marketing & Operations North America – Generics, Biosimilar & Market Access Associate Director, Commercial Technology Business...  ...and help more patients gain access to low‑cost, high‑quality medicines, sustainably. Our momentum is powered by an... 
    Work at office
    Local area
    Remote work
    Relocation
    Relocation package
    Flexible hours

    Sandoz International

    Princeton, NJ
    1 day ago
  • ## Strategy and Operations, Associate DirectorPrinceton - NJ - US# **Position:** Strategy and Operations, Associate Director# **Location**: Central New Jersey**Function Summary**Data and...  ...policies, regulatory requirements, and quality standards.**Qualifications &... 
    Full time
    Temporary work

    Bristol-Myers Squibb Company

    Princeton, NJ
    5 days ago
  • $175.31k - $212.44k

     ...aren’t words that are usually associated with a job. But working at...  ...Responsibilities • Develop the Quality Narrative (or equivalent) at...  ...accurately translated into operational plans. • Assist the...  ...Ripley. R1603518 : Associate Director, Quality Risk Management... 
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    5 days ago
  • $153k - $267k

     ...for providing tactical leadership and direction for pharmacy operations within the enterprise patient support ecosystem. Sets strategic...  ...and organizational scalability. Relationships Reports to the Director, Alt Models Ops. Provides strategic advisement to senior leadership... 
    Temporary work
    Local area
    Flexible hours
    Night shift

    Initial Therapeutics, Inc.

    Plainsboro, NJ
    4 days ago
  • $164.53k - $245.99k

     ...Summary: The Global Integrated Evidence Operations, Associate Director role oversees and coordinates the operational processes, digital system...  ...Overseethe digitalIEPplanning platform/repository andmonitordata quality Ensure operational excellence through the continued... 
    Temporary work
    Local area
    Flexible hours

    Otsuka America Pharmaceutical Inc.

    Trenton, NJ
    6 days ago
  •  ...span several therapeutic areas. Currently they are seeking an Associate Director of Biostatistics to support registration-directed clinical...  ...Oversee AdaM specifications and guide the creation of high-quality, submission-ready datasets and outputs. Drive statistical... 
    3 days per week

    Penfield Search Partners

    Princeton, NJ
    28 days ago
  • $169.22k - $253k

     .../PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R, etc. Excellent working knowledge of phase I clinical operations, drug development, multi‑region regulatory requirements. Good working knowledge of formulation development, drug development and... 
    Contract work
    Temporary work
    Flexible hours

    Otsuka Pharmaceutical Co., Ltd

    Princeton, NJ
    4 days ago
  •  ...needs. The role The role of Program Safety Lead is a director level position here at Ascendis and this Lead will report to the...  ...internationally Office location: This is a hybrid role operating out of Princeton, NJ Applications will be evaluated when received... 
    Temporary work
    Work at office
    Immediate start
    Flexible hours

    Ascendis Pharma

    Princeton, NJ
    19 days ago
  • $80k - $90k

     ...Description Job Description Princeton Day School is seeking an Associate Director of Annual Giving who will report to the Director of...  ...this position, the ideal candidate is expected to: Support operations for The PDS Fund through execution of appeals, stewardship,... 
    Full time
    Part time
    Work at office
    Afternoon shift

    Princeton Day School

    Princeton, NJ
    24 days ago
  •  ...Scorpion Therapeutics in Princeton, NJ, is seeking an Associate Director, Forecasting, to independently develop and maintain forecasts for therapeutic areas. The role requires advanced forecasting methodologies and analytics to inform brand strategy. The ideal candidate... 

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago
  • $155k - $193.2k

     ...average. Position Summary The Associate Director will be responsible for the oversight...  ...approval requirements. Monitors CROs for quality and compliance in the conduct of...  ...and the use of hands for handling or operating equipment. The employee may also need... 
    Work at office
    Local area
    Remote work
    Night shift
    3 days per week

    ACADIA Pharmaceuticals

    Princeton, NJ
    2 days ago
  •  ...Scorpion Therapeutics in Princeton, NJ is looking for an Associate Director in Forecasting. The ideal candidate will lead the forecasting...  ...insights. They will develop advanced forecasting models and ensure quality control. Candidates should have significant experience in... 
    Flexible hours

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago
  • $156k - $234k

     ...Legend Biotech USA is seeking an Associate Director for the PV QA team in Princeton, NJ. The role involves leading quality audits, mentoring auditors, and supporting stakeholders across various departments, focusing on GVP compliance. Candidates should have a Master's... 

    Legend Biotech

    Princeton, NJ
    4 days ago
  •  ...Position Summary The Associate Director, Forecasting, Neuroscience, independently develops, maintains...  ...on hands‑on model execution, rigorous quality control, and AI‑first forecasting tools...  ...cross‑functional partners. Ability to operate in a dynamic environment, manage... 
    Temporary work
    Worldwide
    Flexible hours

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago
  •  ...Bristol-Myers Squibb is seeking an Associate Director, Medical Scientist in Global Medical Oncology for IO Lung Cancer in Princeton, NJ. This role involves developing and implementing medical strategies in non-metastatic lung cancer and collaborating with various teams... 

    Bristol-Myers Squibb Company

    Princeton, NJ
    5 days ago
  •  ...biopharmaceutical company in Princeton, NJ is seeking an Associate Director, TMF Operations to manage electronic Trial Master File processes across...  ...TMF management. Responsibilities include overseeing TMF quality, ensuring inspection readiness, and collaborating with stakeholders... 

    SystImmune Inc.

    Princeton, NJ
    4 days ago
  • $169.22k - $253k

     ...Analytics & Insights team reporting into Senior Director Payer Analytics, with a focus on CNS...  ..., Sales, Business Analytics, and Sales Operations. Work closely with Market Access,...  ...applicable) to improve data readiness, analytic quality/QA, and repeatability of recurring... 
    Temporary work
    For contractors
    Flexible hours

    Otsuka Pharmaceutical Co., Ltd

    Princeton, NJ
    4 days ago
  • $166.35k - $201.57k

     ...changing. Those aren't words that are usually associated with a job. But working at Bristol...  ....com/working-with-us. The Associate Director, Global Medical Affairs, SLE is a core...  ...stakeholder management, strategy, and operations Team and goal oriented with a passion... 
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb Company

    Princeton, NJ
    4 days ago
  • $148.29k - $259.51k

     ...Initial Therapeutics, Inc. is seeking an Associate Director, Medical Affairs Omnichannel Engagement to support their omnichannel strategy across therapeutic areas. This role emphasizes scientific engagement and collaboration with key stakeholders. Ideal candidates will... 
    Remote work

    Initial Therapeutics, Inc.

    Plainsboro, NJ
    5 days ago
  • $169.22k - $253k

    ## **Position Summary:**The Associate Director, CDMO Alliance Management, GEM will serve as Otsuka...  ...CDMOs accountable for delivery and quality.* Support comprehensive risk assessments...  ...Quality Team to ensure commercial and operational viability.**Internal and External... 
    Contract work
    Temporary work
    Local area
    Flexible hours
    Shift work

    Otsuka Pharmaceutical Co., Ltd

    Princeton, NJ
    4 days ago
  • $145.4k - $181.7k

     ...; San Diego, CA Position Summary The Associate Director, Vendor & Relationship Management will...  ...functional service providers to ensure operational excellence, compliance, and value delivery...  ...with R&D stakeholders, Procurement, Quality, Finance, and Legal to enable... 
    Work at office
    Local area
    Remote work
    Night shift

    ACADIA Pharmaceuticals

    Princeton, NJ
    4 days ago
  •  ...Merck & Co. is seeking an Associate Director, Medical Affairs Omnichannel Engagement to enhance its medical omnichannel engagement strategy...  ...support and govern the strategy while leveraging strong operational management and digital project experience. Applicants should... 
    Remote work

    Merck & Co. Inc

    Plainsboro, NJ
    4 days ago
  •  ...Associate Director, Artificial Intelligence, Policy and Channel (AIPC) Responsibilities Design, develop, and deploy scalable end-to-end ML pipelines for Market Access, Pricing, and Value Demonstration. Set technical standards (reliability, scalability, maintainability... 
    Flexible hours

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago
  • Responsibilities Partner with internal stakeholders to ensure launch readiness for CAR T in autoimmune disease. Lead US medical education initiatives aligned to HCP needs and launch priorities. Optimize medical materials in partnership with Medical, Legal, Regulatory, ...
    Local area
    Flexible hours

    Scorpion Therapeutics

    Princeton, NJ
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, Quality Operations. Be the first to apply!