Associate Director Quality Assurance - GmbH

Primary Responsibilities :

• Provide support to QP activities as needed to ensure timely market release of Acadia product as required.
• Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.
• Participates in design, implementation and management of the Acadia GMP quality management system, based on EMA / MHRA and other applicable international regulations
• Ensures compliance of the Acadia GMP quality management system with 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 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
• Provides guidance to Quality Operations teams for investigations, change management and batch record, review, and establishing effective CAPA plans
• Participates in and / or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards
• 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 : Continued Process Verification, Management Review, strategic planning efforts, etc., as may be required
• Participates in and / or leads 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

Education / Experience / Skills :

Pharm D, Master s or Bachelor’s degree in Chemistry / Biology / Pharmacy or related life science is required. A minimum of 8 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry.

Key Skills :

• 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% may be required (including international)

Physical Requirements :

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel;

reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and / or move up to 15 pounds.

Ability to travel by car, train, bus or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues.

In manufacturing plants : appropriate personnel gowning and protective equipment per site and area requirements, including but not limited to safety shoes, safety glasses / goggles, safety helmet, hearing protection and other requirements including but not limited to no jewelry, watch, cell phone, perfume / cologne, cosmetics (per site requirements).

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.

Salary Range

CHF146,000 — CHF182,300 CHF

What we offer you (US-Based Employees) :

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• 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
• 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave
• Tuition assistance
Vor 30+ Tagen