Sodexo is seeking an experienced Quality Assurance Manager to oversee QA and Compliance at our clients’ pharmaceutical manufacturing location in Kalamazoo, MI. This is an exciting opportunity to join one of the best worldwide companies with endless options and opportunities for career growth! If you are searching for a new opportunity in the Life Sciences environment, then look no further. Sodexo has an immediate opening in Kalamazoo MI. We are looking for your expertise in ISO-based Quality Management Systems, internal and external auditing, CAPA management, as well as metrics tracking to help ensure compliance within the pharmaceutical manufacturing environment. This is a client-facing position.
- Solid understanding and practical experience working in a GMP regulated environment is essential.
- In depth knowledge and experience working in a pharmaceutical regulated (GxP) environment, and the standards which must be met to assure 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
- Corrective/Preventive Action Management.
- The ability to write persuasive and effective reports/communications, which clearly define findings, their root causes, and recommendations regarding change is essential.
Must possess strong analytical, organizational, and communication skills:
- The ability to systematically gather and analyze information from a variety of sources, identify implications of data, draw appropriate conclusions, develop viable solutions and alternatives, evaluate the consequences and of each alternative, all the while mitigating risk to both the client and Sodexo.
- The ability to organize not only documentation and data, but also resources to develop positive outcomes to regulatory challenges.
- Excellent communications skills (verbal and written) are required as this role interacts with senior client representatives and senior Sodexo staff. Fluent English plus other relevant major languages is an advantage.
- To provide guidance as the Quality Assurance SME at the client site.
- To lead compliance assessments of GxP and non-GxP related services while adhering to schedules, deadlines, and milestones. These services may include:
- Distribution logistics
- GMP cleaning
- Pest control
- Instrumentation services
- Records services
- Technical lab services
- 3rd party contract management
- Waste disposal
- Functioning as the lead investigator to analyze root-causes and determine proper implementation path(s) for corrective actions when GxP deficiencies are discovered.
- Manage and develop the quality program at the site as well has have significant impact upon the portfolio level quality program.
- Present quality related topics to local client management and Sodexo site and corporate leadership.
- 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.
- Function as a leader, or as an SME for various processes (including change control, risk management, GxP related training, 3rd party vendor management, etc.) in support of compliance to relevant standards.