Requirements: English
Company: WhatJobs
Region: Basel , Basel-City
Job Responsibilities
- Provide support to QP activities as needed to ensure the timely market release of Acadia products.
- Oversee CMOs from a quality perspective, review, and approve CMO Quality Documentation.
- Participate in the design, implementation, and management of the Acadia GMP quality management system, aligned with EMA / MHRA and other international regulations.
- Ensure compliance of the GMP quality management system with EMA / MHRA and other applicable international quality standards.
- Serve as a key contact with CMO partners, ensuring coordinated activities related to cGMP production and continuous improvement.
Additional Responsibilities
- Participate in GMP supplier audits and manage documentation control systems.
- Oversee technology transfer, process validation, batch documentation, registration review, process changes, and deviations with CMO partners.
- Review and ensure conformance to Quality Agreements with GMP contract service providers.
- Guide Quality Operations teams in investigations, change management, batch review, and CAPA planning.
- Lead or participate in continuous improvement initiatives for the quality management system.
- Recommend policy changes and establish procedures affecting the department and possibly the company.
- Engage in Quality Operations functions such as Continued Process Verification, Management Review, and strategic planning.
- Lead risk assessment activities and develop metrics for product and process review.
- Develop department goals aligned with strategic planning and perform other duties as assigned.
Qualifications
Pharm D, Masters, or Bachelors degree in Chemistry, Biology, Pharmacy, or related life sciences, with at least 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry.
Key Skills
- Knowledge of QA activities and international GMP regulations (ICH, Swissmedic, EMA, MHRA).
- Proficiency in interpreting and implementing cGMP regulations.
- Experience with quality management systems, audits, and inspections is advantageous.
- Strong communication, leadership, organizational, and multitasking skills.
- Experience in a global context, preferably in the EU or Switzerland.
- Fluent in English; additional European languages are a plus.
Physical and Other Requirements
Ability to perform typical office and manufacturing plant activities, including occasional lifting and travel up to 20%. Compliance with site-specific gowning and safety protocols is required.
Compensation and Benefits
Salary range: CHF146,000 CHF182,300, with discretionary bonuses and equity awards. Benefits include health insurance, 401(k), stock purchase plan, paid holidays, sick leave, parental leave, and tuition assistance.
Location
Basel, Basel-Stadt, Switzerland
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