Senior Manager, Quality Assurance

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Supervise CMOs from a quality standpoint as designated and carry out the review and approval of CMO Quality Documentation.

• Oversees the Acadia batch disposition process for API, Drug Product, Raw materials, and Intermediates.

• Engages in the design, implementation, and management of the Acadia GMP quality management system, aligning with Swissmedic/EMA/MHRA and other relevant international regulations.

• Guarantees that the Acadia GMP quality management system adheres to Swissmedic/EMA/MHRA and applicable international quality management regulations.

• Acts as a primary contact for CMO partners, ensuring integrated and coordinated activities related to cGMP production and continuous improvement.

• Involved in GMP supplier audits and the Acadia documentation control systems as necessary.

• Oversees and/or provides guidance to QA personnel engaged in CMO technology transfer, process validation, batch documentation, registration batch review, and process changes and deviations.

• Participates in the review and ensures adherence to Quality Agreements with GMP contract service providers involved in outsourced operations.

• Manages internal investigations and change management, establishing effective CAPA plans while ensuring oversight of CMO investigations and change management activities.

• Engages in and/or leads QA in the continuous enhancement of Acadia quality management systems in accordance with GMP and current industry standards.

• Ensures appropriate QA representation on all GMP product development teams; provides guidance to QA representatives within these teams.

• Suggests policy modifications and formulates procedures that impact the functional area, potentially influencing the company as a whole.

• Participates in Quality Operations functions such as: Material Review Board, quality board, strategic planning initiatives, etc., as required.

• Involved in formal risk assessment activities as needed.

• Develops and/or contributes to metrics to support product and/or process review initiatives as required.

• Formulates department goals and objectives for senior management evaluation in alignment with Acadia's strategic planning.

• Other duties as assigned or required.

⛳️ Requirements

• Pharm D, Master’s, or Bachelor’s degree in Chemistry/Biology/Pharmacy or a related life science is mandatory. A minimum of 5 years of relevant and progressively responsible experience in the pharmaceutical or biopharmaceutical industry is required.

• Proven knowledge of Quality Assurance activities and International Conference on Harmonization (ICH), Swissmedic/EMA/MHRA, and other international GMP regulations as they pertain to clinical trials, product development, commercial requirements, and technology transfer.

• Demonstrated competence in interpreting cGMP regulations for Swissmedic/EMA/MHRA and other international regulations.

• Experience in implementing and managing quality management systems is a plus.

• Background in conducting internal and supplier audits and manufacturing facility inspections is advantageous.

• Capability to interpret and apply Quality standards for implementation and review.

• Strong emphasis on adaptability, multitasking ability, attention to detail, excellent organizational skills, good follow-up and judgment, and prioritization skills.

• Proficient in effectively communicating departmental or area issues and results across functional areas, as well as delivering presentations on technical information related to specific projects or timelines.

• Capable of gaining cooperation from others.

• Skilled in effectively leading a collaborative team effort and organizing resources to meet team objectives.

• Able to make and prioritize process and resource decisions based on overall team requirements.

• Experience in a global organization; preferably in the EU or Switzerland.

• Fluent in both spoken and written English (additional European language(s) is a plus).

• Willingness to travel 25-40%, including internationally, may be necessary.

🏝️ Benefits

• Competitive base salary, bonus, new hire, and ongoing equity packages.

• Medical, dental, and vision insurance coverage.

• 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.

• 13 -15 paid holidays, including office closure between December 24th and January 1st.

• 10 days of paid sick leave.

• Paid parental leave benefit.

• Tuition assistance provided.