Your future, so sodexo

Quality Assurance Manager

Job category: Finance

Job ID: 65655

US-MA-ANDOVER

Posted: 23-Nov-2017

                   Quality Assurance Manager

Sodexo is seeking an experienced Quality Assurance Manager for our client pharma manufacturing location in Andover, Mass. This is an exciting opportunity to join one of the best worldwide companies with endless options for career growth!  If you are searching for a new opportunity in QA and Compliance in a Life Science environment, look no further. Sodexo has an immediate opening in Andover MA.  We are looking for your expertise in ISO 9001 quality management systems, internal audit, root cause investigations and CAPA management in a manufacturing and pharma environment.  This is a client-facing position. 

 

Essential Knowledge:

  • Solid grounding and practical experience working in a GMP regulated environment is essential.  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 are a plus.  The candidate must also have a solid background in all aspects of audit management including, internal and external regulatory auditing.
  • Root Cause investigations and Corrective/Preventive Action Management experience including, the ability to write persuasive and effective reports and communications, which clearly define findings and their causes, and recommendations made.
  • Analytical Skills: Must possess strong analytical skills. 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, and evaluate the consequences of choosing each alternative.
  • As this role interacts with senior client representatives, and senior Sodexo staff, excellent communications skills (verbal and written) are required, with an ability to recognize the values within different cultures and acknowledge different ways of working.
  • Fluent English plus other relevant major languages is an advantage.

 

ACCOUNTABILITIES

  • Function as Quality Assurance SME at client site to lead the L1 assessments of GxP and non-GxP related services which Sodexo provide to CLIENT as included in the annual L1 schedule. These services may include Distribution and Logistics, GMP cleaning, Pest control, Lab services, Records services, Technical lab services, 3rd Party contract management, and Waste disposal.
  • Work with CLIENT and Sodexo teams to investigate, analyze root-causes and implement corrective actions where GxP deficiencies are discovered, functioning as the Lead Investigator for these investigations.
  • Present quality related topics to local CLIENT management.
  • 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.
  • Execute and/or lead/function as SME for various processes (including change control, risk management,, GxP related training, and 3rd party vendor management) in compliance to relevant standards.
  • Supplier Assessments and Qualifications

 

 

Basic Education Requirement - Bachelor’s Degree 

Basic Management Experience - 3 years   

Basic Functional Experience - 3 years of experience in QA or R&D in a food manufacturing environment with knowledge of food processing regulations (e.g., USDA, FDA)

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