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Senior Manager, Quality Assurance
Acadia Pharmaceuticals Inc.Senior Manager overseeing Quality Assurance processes in pharmaceutical manufacturing with Acadia. Ensuring compliance with EU GMP and working with diverse teams for product safety.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance within the pharmaceutical manufacturing industry, with a strong focus on EU GMP and GDP guidelines. Capable of managing supplier oversight, conducting audits, and driving continuous improvement initiatives while ensuring data integrity and effective communication across cross-functional teams.
Highest-signal resume keywords
Quality Management Systems (QMS)EU GMP KnowledgeElectronic Quality Management Systems (Veeva Vault, TrackWise)Supplier Oversight ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AssuranceDeviation ManagementCAPA ImplementationChange ControlInternal AuditsSupplier AuditsRegulatory InspectionsRisk ManagementData Integrity ComplianceProject Management
Soft Skills
Attention to DetailNegotiation SkillsStakeholder ManagementProblem-SolvingCommunication Skills
Tools & Technologies
Veeva VaultTrackWiseElectronic RecordsElectronic Signatures
Industry Keywords
Pharmaceutical ManufacturingGMDP ActivitiesQuality Risk ManagementTemperature Excursion ManagementRecall Readiness
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
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