1+ months

Senior Manager, Laboratory Systems Quality & Compliance

Sodexo
Framingham, MA 01702

Unit Description

Sodexo is seeking a Senior Quality and Compliance Manager in the greater Boston area.  A Life Science (Pharmaceutical) campus in Framingham, MA. The campus includes R&D, manufacturing and administrative Operations environments.

 

Responsibilities include but not limited to:

 

  • Manage client Quality and Compliance related duties, to ensure that resources are appropriately applied and utilized, in the delivery of quality and compliance support to the Sodexo operational teams.
  • Perform audits of all GxP services which Sodexo provide to our client; which includes: 
  • Contract management, equipment and lab instrument services and facilities management (e.g. buildings/equipment maintenance, calibration, qualification).
  • Support the development and continuous improvement of the Global Quality Management System for Sodexos pharma business.
  • Work with client and Sodexo teams to investigate root-causes, analyze and implement corrective action and preventative actions, particularly where GxP deficiencies are noted.
  • Present quality related topics to the client, local management and quality management.
  • Perform investigations and special projects as required by Sodexo senior management locally and for the C of Excellence Quality and Compliance Team.
  • Maintain communication with key Sodexo and client personnel.
  • Provide guidance and assistance to Quality and Compliance staff (Sodexo and client).
  • Conduct training in GxP and QMS topics, to the wider Sodexo operations team.
  • Support business development and new business for Sodexo.
  • Execute various processes (e.g. QMS / documentation control, change control, risk management, non-conformance and CAPA management, 3rd party management) in compliance to relevant standards.

 

Our idea candidates should have:

  • A solid grounding and practical experience in working in the Pharmaceutical environment, particularly in a Quality function, laboratories and facilities management areas.
  • In-depth knowledge of working in a Pharmaceutical regulated (GxP) environment, and the standards which must be met to assure patient safety and product quality.
  • A good background in auditing and reporting
  • Ability to write persuasive and effective reports and communications, which clearly define findings and their causes, and recommendations made.
  • The ability to systematically gather information from a variety of sources, analyze information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem
  • The ability to apply Quality Risk Management processes to evaluate the consequences of choosing each alternative. 
  • Excellent communications skills (verbal and written)

 

Fluent English + other relevant major languages is a plus

 

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., KPIs, Project Management)

Qualifications & Requirements

Basic Education Requirement - Bachelors Degree or equivalent experience

Basic Functional Experience 3 years

 

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

Categories

Posted: 2019-12-12 Expires: 2020-02-15

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Senior Manager, Laboratory Systems Quality & Compliance

Sodexo
Framingham, MA 01702

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