Senior Manager, Quality Assurance

Acadia Pharmaceuticals Inc.

Sr. Manager overseeing quality assurance operations within Acadia Pharmaceuticals.

Posted 7/31/2026full-timeRemote • 🇨🇭 SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance activities, compliance with cGMP regulations, and management of quality management systems within the pharmaceutical industry. Proficient in conducting audits, managing investigations, and leading continuous improvement initiatives.

Highest-signal resume keywords

Quality Assurance ActivitiesCGMP Regulations ComplianceQuality Management Systems ManagementInternal and Supplier AuditsPharm D or Related Degree

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Documentation ReviewBatch Disposition ManagementGMP Quality Management System ImplementationChange ManagementCAPA Plans DevelopmentRisk AssessmentMetrics DevelopmentProcess ValidationTechnology TransferQuality Agreements Review

Soft Skills

Attention to DetailExcellent Organizational SkillsEffective CommunicationTeam LeadershipFlexibility

Industry Keywords

Pharmaceutical IndustryBiopharmaceutical IndustrySwissmedicEMAMHRAICHCGMPClinical TrialsProduct DevelopmentGlobal Organization Experience

About the role

Key responsibilities & impact

Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.
Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates
Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations
Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations
Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement
Participates in GMP supplier audits and Acadia documentation control systems as needed
Manages and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations
Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations
Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation and change management activities.
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 product development teams; provides direction to 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 Quality Operations functions such as: Material Review Board, quality board, strategic planning efforts, etc., as may be required
Participates in formal risk assessment activities as required
Develops and/or contributes metrics to support product and/or process review efforts as needed
Develops department goals and objectives for senior management review in alignment with Acadia strategic planning
Other duties as assigned/required

Requirements

What you’ll need

Pharm D, Master´s or Bachelor’s degree in Chemistry/Biology/Pharmacy or related life science is required. A minimum of 5 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry.
Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and Swissmedic/EMA/MHRA and other international GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer
Demonstrated proficiency in interpretations of cGMP regulations for Swissmedic/EMA/MHRA and other international regulations.
Experience implementing and managing quality management systems is an advantage
Experience conducting internal and supplier audits and manufacturing facility inspections is an advantage
Ability to interpret and relate Quality standards for implementation and review
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize
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.
Able to gain cooperation of others
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 needs
Experience in a global organization; ideally in the EU or Switzerland
Fluent in spoken and written English (additional European language(s) an advantage)
Travel 25-40% may be required (including international)

Benefits

Comp & perks

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