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Sr. Manager, Quality Assurance

1 day, 1 hour ago
Switzerland
Full-time
Senior
QA Engineer
Quality Assurance and Testing
Apply Now
Acadia Pharmaceuticals

Acadia Pharmaceuticals

Acadia Pharmaceuticals, with over 30 years of experience, pioneers essential therapies for Parkinson's disease psychosis and Rett syndrome, while focusing on addressing negative symptoms in various disorders.

Pharmaceuticals
251-1K
Founded 1993
$101M raised
View All Jobs 6

Description

  • Oversee assigned CMOs from a quality perspective and review and approve CMO quality documentation.
  • Manage the batch disposition process for API, drug product, raw materials, and intermediates.
  • Participate in the design, implementation, and management of the GMP quality management system.
  • Ensure compliance with Swissmedic, EMA, MHRA, and other applicable international regulations.
  • Serve as a key point of contact for CMO partners and coordinate cGMP production and continuous improvement activities.
  • Participate in GMP supplier audits and documentation control activities.
  • Provide oversight for QA personnel supporting technology transfer, process validation, batch documentation, registration batch review, process changes, and deviations.
  • Review and ensure conformance to quality agreements with GMP contract service providers.
  • Manage internal investigations and change management, and establish CAPA plans.
  • Support continuous improvement of quality management systems, risk assessments, metrics, and department goals.

Requirements

  • PharmD, Master’s, or Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related life science field is required.
  • Minimum 5 years of related and progressively responsible experience in the pharmaceutical or biopharmaceutical industry.
  • Demonstrated knowledge of QA activities and ICH, Swissmedic, EMA, MHRA, and other international GMP regulations.
  • Demonstrated proficiency in interpreting cGMP regulations for Swissmedic, EMA, MHRA, and other international requirements.
  • 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 apply quality standards for implementation and review.
  • Strong flexibility, multitasking, attention to detail, organizational, follow-up, judgment, and prioritization skills.
  • Experience in a global organization, ideally in the EU or Switzerland.
  • Fluency in spoken and written English; additional European language(s) is an advantage.
  • Travel 25–40% may be required, including international travel.

Benefits

  • Competitive base salary, bonus, and new hire/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 of 1:1 up to 5%.
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in.
  • 15+ vacation days and 13–15 paid holidays, including office closure from December 24 to January 1.
  • 10 days of paid sick time and paid parental leave.
  • Tuition assistance.

Interested in this position?

Apply directly on the company website

Apply Now

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