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 Senior Manager, Laboratory Systems Quality & Compliance - MOSELEY, Virginia, United States

   
Job information
Posted by: Sodexo 
Hiring entity type: Food Service and Restaurant 
Work authorization: Existing work authorization required for United States
Position type: Direct Hire, Full-Time 
Compensation: ******
Benefits: See below
Relocation: Not specified 
Position functions: Hospitality/Tourism
Operations - Quality
 
Travel: Unspecified 
Accept candidates: from anywhere 
Languages: English - Fluent
 
Minimum education: See below 
Minimum years experience: See below 
Resumes accepted in: English
Cover letter: No cover letter requested
Job code: 639627 / Latpro-3762711 
Date posted: Nov-19-2020
State, Zip: Virginia, 23120

Description

Unit Description

Compliance is the backbone of the pharmaceutical and Life Sciences business and therefore must interact with all levels of management and science professionals. When non-compliance or other risk factor arises, this position will be called upon to contribute to the resolution of any quality issues as they arise.

Sodexo, a global leader in Quality of Life Services, Facilities Management is looking for an experienced Sr. Manager Quality & Compliance, in Life Sciences. The Sr. Manager of Quality & Compliance will support Sodexo Integrated Facilities Management (IFM) teams by working to ensure all elements of the Quality Management System are adhered to across the portfolio.

The position will serve as a member of the Corporate Services Quality, Health, Safety, and Environmental team. This individual would support and conduct audits, provide input into training and quality investigations to ensure GxP regulations are satisfied; identify accounts with deficiencies in their quality program and put programs into place to correct deficiencies, work with clients and Sodexo teams to investigate root-causes, analyze and implement corrective actions where GxP deficiencies are discovered.

You will be responsible to ensure full quality and compliance in the life sciences environment; interact with client compliance teams to ensure consistency. The impact of any failure is critical for client and for Sodexo.

While the scientific field is generally specific, this role will be required to navigate between scope of work in contract, to client needs/desires and determine critical needs and priorities to ensure sound judgment on decisions. Projects will be presented that will require analysis and prioritization.

Duties include but not limited to:

  • Ensuring areas are always audit ready (Conducting/Supporting L0-L4 Audits)
  • Incident management. (CAPA management., Déviation Investigations, RCA)
  • System Administration (EQMS, My Learning, CDMS, IMMS, etc.)
  • Technical Writing
  • Other QMS Element Mgmt. (training, change control, risk mgmt., KPI’s, Project Management)

Our ideal candidate will have

  • experience working in a life science and or manufacturing environment
  • experience interfacing with client services; and experience with FDA and other regulatory agencies
  • Understand cGMPs as they relate to pharmaceutical manufacturing and R&D operations.
  • Internal and supplier audit experience
  • Investigative and technical writing skills


Position Summary

This position reports into the Sodexo Global Quality Assurance and Compliance Group and is focused on supporting GxP and Compliance activities at Pharmaceutical and Life Science sites. Supporting Sodexo Integrated Facilities Management (IFM) teams, the QA and Compliance Manager works _to ensure all elements of the Quality Management System are adhered to. Primary duties include:

  • Ensuring areas are audit ready at all times (Conducting/Supporting L0-L4 Audits)
  • Incident mgmt. (CAPA mgmt., Deviation Investigations, RCA)
  • System Administration (EQMS, My Learning, CDMS, IMMS, etc.)
  • Technical Writing
  • Other QMS Element Mgmt. (training, change control, risk mgmt., KPI’s, Project Management)


Requirements

Basic Education Requirement - Bachelor’s Degree or equivalent experience

Basic Functional Experience – 3 years

 

Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer.


 

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