Quality Systems Manager

Fullscript-posted about 1 year ago
Full-time • Mid Level
Onsite • Remote, OR
10,001+ employees
Ambulatory Health Care Services
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The Quality Systems Manager at Fullscript is responsible for overseeing the electronic Quality Management System (eQMS), ensuring its compliance with regulatory requirements and supporting business operations. This role involves managing key quality processes, driving continuous improvement initiatives, and collaborating with various teams to enhance the effectiveness of quality systems and processes.

  • Manage the electronic Quality Management System (eQMS) including its configuration, implementation, and maintenance.
  • Oversee the document control process, ensuring documentation is complete, approved, and archived efficiently.
  • Lead the implementation of Corrective and Preventive Actions (CAPA) practices and provide metrics for the CAPA process.
  • Develop and implement a training program for Quality Management System training.
  • Conduct internal quality audits and participate in external audits (FDA, NSF, State, Customer).
  • Ensure compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures.
  • Perform verification and validation activities and develop Standard Operating Procedures (SOPs).
  • Guide team members in enhancing their skills with quality processes and foster a culture of quality excellence.
  • 10+ years of regulatory/quality assurance experience within a regulated industry (food, dietary supplement, drug, or medical device).
  • Proven leadership experience in developing, implementing, and maintaining QMS processes.
  • Expert working knowledge and experience in eQMS; ZenQMS experience preferred but not required.
  • Proficiency in Google Suites and/or Microsoft Office applications.
  • Working knowledge of regulations relevant to Foods, Dietary Supplements, OTC, Medical Devices, and/or Cosmetic products.
  • Thorough understanding of cGMP requirements.
  • Meticulous attention to detail and superior organizational capabilities.
  • Proactive self-starter with the ability to drive tasks to completion autonomously.
  • Exceptional verbal and written communication skills.
  • Competitive Total Rewards offerings
  • 401(k) savings plan & matching (within US)
  • Customizable Health Benefits
  • Flexible Paid Time Off program
  • Discounts on Fullscript catalog of products for self, family & friends
  • Training allowance and company-wide learning initiatives
  • Remote work options with flexibility in office location.
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