Position Summary:
The Senior Manager, Quality Assurance, plays a key role in supporting the release and distribution of commercial medicinal products across the EU/EEA. This position is responsible for overseeing critical Quality Management System (QMS) activities and ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and applicable EU regulatory requirements. The role partners closely with internal and external stakeholders to maintain product quality, patient safety, and regulatory compliance throughout the product lifecycle.
Primary Responsibilities:
- Lead and support core QMS processes, including Management Review and Annual Product Quality Reviews (APQRs).
- Review batch documentation and support commercial product release activities, including deviation management, CAPA implementation, and change control.
- Plan, conduct, and follow up on internal audits, supplier audits, and regulatory inspections.
- Drive continuous improvement initiatives and support quality risk management.
- Manage supplier oversight activities, including qualification, performance monitoring, and revisions of quality agreements.
- Support GDP compliance programs, including transportation and distribution oversight, warehousing activities, temperature excursion management, customer qualification, and recall readiness.
- Ensure compliance with data integrity requirements and governance of computerized systems, electronic records, and electronic signatures.
- Collaborate with Regulatory Affairs, Manufacturing, Supply Chain, Distribution, and other cross-functional teams to support compliant product release and distribution activities.
- Identify, assess, and escalate quality and compliance risks as appropriate.
Education/Experience/Skills
- Bachelor’s degree in a Health Science discipline required; Master’s degree preferred. Equivalent combinations of education and relevant experience will be considered.
- Minimum 5 years of experience within the pharmaceutical manufacturing industry with focus on quality assurance.
- Strong knowledge of EU GMP (EudraLex Volume 4), EU GDP Guidelines (2013/C 343/01), Directive 2001/83/EC, ICH Q7, Q9, and Q10, and other relevant regulatory requirements.
- Proven experience managing outsourced GMDP activities.
- Hands-on experience with electronic quality management systems such as Veeva Vault, TrackWise, or equivalent platforms.
- Strong organizational and project management skills with the ability to manage multiple priorities simultaneously.
- Excellent attention to detail and commitment to quality.
- Effective negotiation and stakeholder management skills.
- Ability to independently assess complex situations, resolve issues, and recommend practical solutions.
- Strong risk-based decision-making and problem-solving capabilities.
- Excellent written and verbal communication skills with the ability to convey complex information to diverse audiences.
- Demonstrated ability to build collaborative relationships and work effectively across functions and external partners.
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 9 kilograms. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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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.
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 [email protected] 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.
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.
Skills Required
- Bachelor's degree in a Health Science discipline or equivalent experience
- Master's degree
- Minimum 5 years experience in pharmaceutical manufacturing with focus on quality assurance
- Strong knowledge of EU GMP (EudraLex Volume 4), EU GDP Guidelines, Directive 2001/83/EC, ICH Q7, Q9, and Q10
- Proven experience managing outsourced GMDP activities
- Hands-on experience with electronic quality management systems such as Veeva Vault or TrackWise
- Experience with supplier qualification, performance monitoring, and quality agreements
- Experience planning, conducting, and following up on internal, supplier, and regulatory audits
- Strong organizational and project management skills with ability to manage multiple priorities
- Excellent attention to detail and commitment to quality
- Effective negotiation and stakeholder management skills
- Ability to assess complex situations independently and recommend practical solutions
- Strong risk-based decision-making and problem-solving capabilities
- Excellent written and verbal communication skills
- Demonstrated ability to build collaborative cross-functional and external partnerships
- Ability to travel independently overnight and work after hours as required
What We Do
Our Acadia family of care-ageous warriors aspire to enable brighter moments for patients and their loved ones. For 30 years, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. Important Notice for Candidates - Be Aware of Fraudulent Recruiting Activity Acadia Pharmaceuticals has become aware of fraudulent recruiting activity being circulated via email and LinkedIn by individuals impersonating Acadia Talent Acquisition employees. These communications may appear legitimate due to an official-looking Acadia email address or website, referencing of an actual recruiter and/or manager at Acadia (easily found on LinkedIn), and/or offer documents falsely signed by an Acadia executive. The impostor uses the incentive of a job interview and job offer to solicit sensitive personal information from the intended victim. Please note that the Acadia Talent Acquisition and HR Team will ONLY interact with a candidate from "Acadia-pharm.com" domain sourced emails. We do not request sensitive personal information, such as a Social Security Number, or payments of any kind during the interview or job offer process. Acadia strongly recommends individuals, who receive email solicitations, to carefully verify the authenticity of the correspondence before responding. Never provide personal information or click on links if you are unsure a communication’s legitimacy. If in doubt, please contact [email protected] to verify.
