Associate Director, Quality Operations at Acadia Pharmaceuticals

<div class="content-intro"><p></p> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow"><strong data-ogsc="" data-olk-copy-source="MessageBody">About Acadia Pharmaceuticals</strong></span></div> <div data-ogsc="black">&nbsp;</div> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow">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.</span></div></div><p><strong>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.</strong></p> <p>&nbsp;</p> <div> <h3>Position Summary</h3> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">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.</div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"> <div> <h3>Primary Responsibilities</h3> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Serve as the primary quality interface with CMOs to ensure compliance with SOPs, Quality Agreements, and regulatory expectations</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Support complaint handling activities, including investigation and closure</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Support the design, implementation, and maintenance of Acadia’s GMP quality management system in compliance with US and international regulations</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Represent Quality Assurance on cross‑functional GMP manufacturing, packaging, supply chain, and development teams</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Other duties as assigned</li> </ul> <p>&nbsp;</p> <h2>Education/Experience/Skills</h2> <p>&nbsp;</p> <ul> <li> <div>Bachelor’s degree in Chemistry, Biology, or a related life science</div> </li> <li> <div>Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry</div> </li> <li> <div>Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations</div> </li> <li> <div>Demonstrated experience with US FDA and international GMP regulations</div> </li> <li> <div>Experience overseeing CMOs and outsourced GMP manufacturing activities</div> </li> <li> <div>Ability to travel up to 15–20%</div> </li> </ul> <p>&nbsp;</p> <h2>Physical Requirements</h2> <p>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.&nbsp; This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.</p> <div class="content-pay-transparency"> <div class="pay-input"> <div class="description"> <p>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.&nbsp;</p> <p><span style="color: rgb(255, 255, 255);">#LI-HYBRID</span></p> <p><span style="color: rgb(255, 255, 255);">#LI-CS1</span></p> </div> </div> </div> <p>&nbsp;</p> </div> </div> </div><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><span style="font-size: 16px;">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.&nbsp;</span></p></div><div class="title">Salary Range</div><div class="pay-range"><span>$145,100</span><span class="divider">&mdash;</span><span>$181,400 USD</span></div></div></div><div class="content-conclusion"><p><strong><span data-contrast="none">What we offer US-based Employees:</span></strong> </p> <ul> <li>Competitive base, bonus, new hire and ongoing equity packages</li> <li>Medical, dental, and vision insurance</li> <li>Employer-paid life, disability, business travel and EAP coverage</li> <li>401(k) Plan with a fully vested company match 1:1 up to 5%</li> <li>Employee Stock Purchase Plan with a 2-year purchase price lock-in</li> <li>15+ vacation days</li> <li>13 -15 paid holidays, including office closure between December 24th and January 1st</li> <li>10 days of paid sick time</li> <li>Paid parental leave benefit</li> <li>Tuition assistance</li> </ul> <p><strong>EEO Statement (US-based Employees): </strong>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.</p> <p>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.</p> <p>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&nbsp;<a href="https://app.smartsheet.com/b/form/43db301ada19415fa7ab365633993f33" target="_blank">Reasonable Accommodation Request Form</a>&nbsp;or contact us at&nbsp;<a href="mailto:[email protected]" target="_blank">[email protected]</a>&nbsp;or&nbsp;<a>858-261-2923</a>.</p> <p>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.</p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">California Applicants: </span></span></strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">Please see </span></span><a href="https://acadia.com/en-us/legal-policies/privacy#18"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Additional Information for California Residents</span></span></a><span data-contrast="none"><span data-ccp-parastyle="heading 4"> within our Privacy Policy.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;335559685&quot;:0,&quot;335559991&quot;:0}">&nbsp;</span></p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">Canadian Applicants: </span></span></strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">Please </span></span><span data-contrast="auto"><span data-ccp-parastyle="heading 4">see</span></span> <a href="https://acadia.com/en-gb/legal-policies/privacy#17"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Additional Information for Canadian Residents</span></span></a><span data-contrast="none"><span data-ccp-parastyle="heading 4"> with</span></span><span data-contrast="auto"><span data-ccp-parastyle="heading 4">in</span></span><span data-contrast="none"><span data-ccp-parastyle="heading 4"> our Privacy Policy.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;335559685&quot;:0,&quot;335559991&quot;:0}">&nbsp;</span></p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: </span></span></strong><span data-contrast="none"><span data-ccp-parastyle="heading 4">Please see <a href="https://acadia.com/en-gb/legal-policies/privacy#16">Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia</a>&nbsp;</span></span><span data-contrast="none"><span data-ccp-parastyle="heading 4">within our Privacy Policy.</span></span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;335559685&quot;:0,&quot;335559991&quot;:0}">&nbsp;</span></p> <p><strong>Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): </strong>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.</p></div>