Opportunities

Quality and Compliance Lead

Glastonbury, CT

If you have a strong background in regulatory compliance and a passion for working with a company in the early stages of their quality and compliance journey, then we encourage you to apply today

Position summary

The Quality and Compliance Lead will be responsible for driving quality improvements across Envision Technology Solutions (ETS). This position will regularly train staff regarding regulatory compliance as it applies to ETS. To be successful, this candidate will be able to demonstrate the following:

Key responsibilities

  • Leading ETS compliance and quality standards; this position has the potential to directly manage employees
  • Managing the quality management system (QMS) including Standard Operating Procedures (SOPs) across all ETS departments by:
    • Assessing current ETS processes and procedures to establish Gap Analysis of current SOPs
    • Logically implementing new and/or revised SOPs
    • Continuously maintaining and improving SOPs within the QMS, ensuring all SOPs are up-to-date and enforced (including regulatory and validation training)
  • Facilitating and managing all external (client or third-party) audits and performing internal audits
  • Supporting the Validation team and their activities, including but not limited to:
    • 21 CFR Part 11 / Annex 11 regulations and changes
    • Change control procedures, infrastructure qualification and ancillary system validation
  • Facilitating and engaging with various departments to come to common consensus on critical processes
  • Supporting quality and compliance Request for Proposal (RFP) responses (including validation)

Skills and experience required

  • Bachelor’s Degree or higher in Business Administration, Software Engineering, or related field
  • Proven track record with 5 to 8+ years in a Lead Quality Compliance position
  • Passion for bringing together disparate and complex processes while leading and influencing teams (direct/indirect resources and business partners)
  • A positive “can-do” attitude with a willingness to drive initiatives to successful completion with demonstrated ability to deliver on promises
  • Excellent MS Office and project management skills
  • Exceptional verbal, written, and interpersonal communication skills
  • A solid understanding of the Software Development Lifecycle (SDLC)
  • Over 2 years’ experience in the software industry is a plus

What is it like working for Envision Pharma Group

Envision Pharma Group is committed to developing and supporting team members, enabling them to excel in their roles, and to maintaining a culture that encourages development, as well as recognizing and rewarding achievements. We are a dynamic and rewarding company to work for, offering excellent benefits and a friendly, supportive, and vibrant work environment.

Click here to download a PDF of the vacancy.

STRICTLY NO AGENCIES

Interested?

Please send your resume and a cover letter to opportunities-US@envisionpharmagroup.com or, alternatively, visit www.envisionpharmagroup.com to find out more about working at Envision.