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Sr Manager, Quality Assurance

Overseeing the quality assurance activities related to our Contract Manufacturing Organizations (CMOs). Ensuring that all products manufactured by CMOs meet our quality standards and comply with regulatory requirements. Establishing and maintaining the integrity and quality of our products while fostering strong relationships with our manufacturing partners.

Reports To: SVP, Quality
Function: Quality
Level: Senior Manager
Location: Switzerland

Key Responsibilities

1. Strategic

• Lead the quality management processes for CMO selection in collaboration with cross functional team
• Develop and implement quality assurance strategies and processes for oversight of CMOs.

2. Operational

• Monitor and evaluate the performance of CMOs to ensure compliance with company standards, regulatory requirements, and industry best practices.
• Coordinate the preparation and execution of audits and inspections, along with the follow-up actions.
• Collaborate with CMO partners to address and resolve any quality-related issues or deviations.
• Review and approve CMO quality documentation, including batch records, deviation reports, and change controls.
• Ensure effective communication and coordination between internal teams and CMOs regarding quality matters.
• Provide training and guidance to CMOs on quality standards and regulatory requirements.
• Prepare and present quality reports to senior management, highlighting key performance indicators, trends, and areas of concern.
• Lead investigations into product quality issues and implement corrective and preventive actions.
• Stay current with industry regulations and standards, ensuring that all quality processes are up-to-date and compliant.

3. Area of focus

• Regulatory Compliance:
  • Understand and apply regulations (such as GMP, GDP) to ensure product quality.
  • Monitor compliance during manufacturing, packaging and processes.
• Quality Systems:
  • Develop and maintain quality management systems (QMS).
  • Implement CAPA (Corrective and Preventive Actions) processes.
• Risk Management:
  • Identify and mitigate risks related to product quality.
  • Conduct risk assessments for processes and products.
• Auditing and Inspections:
  • Prepare for and participate in audits.
  • Prepare supplier inspection
  • Address findings and implement corrective actions.
• Leadership and Communication:
  • Communicate with cross-functional teams, suppliers.

Necessary Skill Set

• Minimum of [8] years of experience in quality assurance within the pharmaceutical, biotechnology, or related industry.
• Proven experience in managing quality assurance activities with CMOs.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA, GMP) and quality management systems.
• Excellent auditing skills and experience in conducting CMO audits.
• Strong problem-solving abilities and attention to detail.
• Excellent communication and interpersonal skills, with the ability to build and maintain strong relationships with CMO partners.
• Ability to work independently and as part of a team in a fast-paced, dynamic environment.
• Proficiency in using quality management software and tools.

1. Qualifications

• Bachelor’s degree in a relevant field such as Chemistry, Biology, Pharmacy, or Engineering. Advanced degree preferred.
• Certification in Quality Assurance or related field (e.g., ASQ CQA, CQE).
• Experience with international CMOs and understanding of global regulatory requirements.

If you wish to apply, please use the application button below and send us your letter of intent and resume.

Oculis is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.