GMP Quality Manager

3 weeks ago


Malvern, Pennsylvania, United States Marken Full time
Job Description

We are seeking a highly motivated Regulatory Compliance Specialist to join our team at Marken, a leading global clinical supply chain solutions provider.

About the Role

This is a challenging and rewarding opportunity to work in a fast-paced environment where you will be responsible for providing support to our CAPA System, Trainings, and Vendor qualification process, as well as records review.

Main Responsibilities
  • Ensure adherence to regulatory requirements and company standards
  • Provide training on quality-related topics to vendors and employees
  • Support the CAPA System and conduct thorough investigations
  • Develop effective action plans and prepare high-quality deviation reports
  • Collaborate with logistics teams to ensure operational effectiveness and compliance
Requirements
  • Bachelor's degree in life sciences or a related field
  • Minimum 3 years of relevant experience in Quality and Logistics, including Pharmaceutical/Biotechnology industry experience
  • Previous experience in Quality Management Systems with attention to detail
  • Strong knowledge of GxP
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team
What We Offer

Marken offers a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) matching program. We also offer opportunities for professional growth and development, as well as a competitive salary range of $75,000 - $95,000 per annum.



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