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Compliance Analyst

Location: 

Milford, CT, US

Req ID:  665
Job Type: 

We are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

Compliance Analyst

 

The primary responsibility of the Compliance Analyst is to ensure continuing excellence and compliance in the records and information management for the Company’s GMP and Regulatory documentation (e.g., health authority inspection and audit reports, communications with regulatory agencies, inspectable executive governance forums including executive management reviews, safety councils, board of director updates, product recall administration).  The incumbent will also administer activities, contracts, and finances with third party medical, regulatory, and quality consultants; facilitate timely and consistent metrics reporting across the global QRS team; maintain QRS communications such as “on hold” notices, inspection notices, and applicable document repositories.  In the event of a product recall, the incumbent will coordinate notifications, recall volume tracking, as well as product destruction in accord with regulatory requirements.  The incumbent will continually improve agility and efficiency across the QRS organization by leveraging technologies that improve information sharing and facilitate virtual teamwork.  The incumbent will maintain applicable documentation in full inspection-ready fashion.

 

Essential Functions:

  • Develop and maintain processes and systems for efficient management of primary GMP and compliance records, including health authority inspection reports, Company responses, executive management reviews, safety councils, board of director updates, and product recall administration. 
  • Develop and sustain compliant processes for SOP review and QRS training maps
  • Track budget compliance against travel, consultant, and project spend.  Generate purchase orders and submit expense reports and invoice payments as necessary. 
  • Gather and report appropriate QRS performance measures. Track and follow up of audit findings to ensure timely completion.  Periodic status report out to Quality Leadership team
  • Ensure full data integrity in Product Information Files (PIF) for Europe, inspection/audit preparation
  • Develop and implement plans to eliminate paper-based systems where they exist
  • Recap QRS leadership meetings and ensure open items and action items are properly captured and addressed
     

Experience/Education Required:

  • College degree preferred; or demonstrated equivalent experience necessary to fulfill position requirements.

 

Skills and Abilities Required:

  • Excellent organizational, prioritization skills to successfully handle multiple priorities and projects simultaneously.
  • Strong computer skills, including all Microsoft applications, as well as SAP and PLM.
  • A solid record of problem solving and priority setting.
  • Effective verbal / written communication and interpersonal skills
  • Ability to interface with internal and external contacts at all levels, and to work with sensitive information.
  • Ability to contribute to positive culture change.
  • Poise to interact with regulatory and governmental bodies in a way that represents company interests

 

*CB*

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Nearest Major Market: New Haven
Nearest Secondary Market: Hartford