Associate Director Quality Assurance and compliance

Job Description:

Associate Director Quality Assurance and Compliance

The Associate Director, Quality Assurance and Compliance (QAC) – Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands-on administration and management of Quality Systems and ensures compliance with Good Clinical Practices (GCP), Electronic Records/Signatures, and the Quality Management System within Veristat Europe.

This role supports the global head of QAC and serves as a liaison for compliance-related activities to all Veristat personnel, providing oversight from a corporate level. Responsibilities include but are not limited to quality management and training, ensuring that Veristat as a company has appropriate policies, procedures, and infrastructure, and that QAC staff are qualified to perform related tasks.

What we do

For more than 30 years, Veristat has built a reputation as global experts in clinical development.

• 760+ Rare Disease Clinical Trials supported
• 160+ Marketing Applications supported
• In 2022 we supported 8 marketing applications that received regulatory approval

What we offer

• The estimated hiring range for this role is 100-150K CHF plus applicable bonus. This hiring range is specific to Switzerland and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to skills and experience, licensure and certifications, education, specific location and dynamic market data.
• Benefits vary by location and may include:
  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retirement plans

What we look for

• Bachelor’s degree required; science-related degree preferred. 8+ years of GCP experience in an FDA, MHRA, EMA, and/or other competent authority regulated environment required, to include a minimum of 5 years in the sponsor and/or Full Service CRO industry preferred, and at least 5 years of supervisory experience required. Equivalent combinations of experience acceptable.
• Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff required.
• Solid understanding of global clinical research regulations, including but not limited to ICH E6 Good Clinical Practice, and 21CFR-Part11 required.
• Knowledgeable in Quality Management System (QMS) design and requirements, including document control, CAPA, and training required.
• Experience with implementation and management of GxP related electronic systems required.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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