Quality Assurance
Vor 6 Tagen
Job Description:
Quality Assurance & Compliance Interface Manager
The Quality Assurance (QA) and Compliance Interface Manager will ensure compliance with relevant guidelines and regulations for GxP System Validation, support IT CSV and changes, and act as System Administrator for Veristat's eQMS MasterControl. The position holder, with the input from the line manager and the QA team, is responsible for performing activities required for the maintenance of Veristat's global QMS, in the context of gap analysis performance and SOP development to ensure the safety and compliance of medicinal products, when releasing to the market.
Make an Impact at Veristat
Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
• approved therapies for marketing applications prepared by Veristat
• oncology projects in the past 5 years
• rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
What we offer
- 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 in IT or a related field required; master's degree preferred.
- 5 or more years of relevant industry experience in Quality Assurance and Computerized Systems, secondary degree in QA related field is desirable but not essential.
- Expert knowledge of CSV according to FDA/European Union (EU) regulations.
- Working experience in quality system programs.
- Excellent written and oral communication skills.
- Proficient in Microsoft Word, Excel and PowerPoint.
- Strong multitasking and organization skills with a high level of attention.
- Demonstrated ability to work in a cross-functional team.
- Well-honed ability to work independently, think critically, take initiative and set priorities, as much as ability to work as part of a team.
- Ability to meet strict deadlines, flex with changing priorities.
- Health Authority and/or Notified Body experience a plus.
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.
#LI-SI1
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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