Senior Manager, Quality Assurance

More information about this job
Unit Description
Sodexo is seeking a talented Quality Assurance Manager for our 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/Compliance in a Life Science environment , look no further. Sodexo has an immediate opening in a new account in Andover MA. We are looking for your expertise in quality management systems such as ISO9001 & other related compliance & quality methodologies. Having experience in a manufacturing and pharma environment is heavily preferred.
Essential Knowledge:
+ Solid grounding and practical experience in working in the Pharmaceutical environment, particularly in laboratories and facilities management areas. The candidate should have an 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. The candidate should also have a good background in auditing.
+ Reporting: 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 recognise the values within different cultures and acknowledge different ways of working.
+ Fluent English plus other relevant major languages is an advantage.
ACCOUNTABILITIES
+ 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, 3 rd 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 3 rd party vendor management) in compliance to relevant standards.
+ Lead the weekly Risk and Compliance update meetings for the US
Position Summary
Ensures corporate and regulatory compliance for the company's quality assurance, food and physical safety initiatives by pro-actively providing technical expertise, training, and support to a geographic region within the division. Manage the crisis resolution process in a timely manner. Manages the region?s Quality Assurance program, including providing direction and support to the field Quality Control Coordinators with emphasis on implementation and maintenance of the Quality Gold Check program, and interacting with and responding to the client?s Quality Assurance audits and auditors.
Qualifications & Requirements
Basic Education Requirement - Bachelor's Degree in public health, food science, or related field.
Basic Functional Experience - 6 years of experience in public health, food safety, or related field.
Sodexo is an EEO/AA/Minority/Female/Disability/Veteran employer.
System ID _57691_
Location _US_ _-_ _MA_ _-_ _ANDOVER_
Relocation _No_
Category _Finance_
Type _Full-Time_ d977e0f478764752809ee4e9759aa422

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