What are the responsibilities and job description for the Quality Assurance Manager position at SQA Services?
Job Overview:
SQA Services is a leading quality consulting firm that partners with multiple Fortune 500 companies in the Life Sciences field. We are seeking an experienced Field Engineering Manager to join our team and lead the design, development, and deployment of internal and suppliers' quality programs.
As a Field Engineering Manager at SQA Services, you will be part of a dynamic team that manages technical design, development, and deployment of Life Sciences clients consulting, audit, inspection, remediation, and improvement programs. You will ensure that all stages of the product lifecycle, from clinical to commercial production and post-market surveillance, are compliant with regulatory guidelines and standards.
Main Responsibilities:
- Work with clients to comprehensively understand and record requirements for program scope execution that maximizes sales and margin for the SQA business model.
- Kick off and monitor managed programs for Life Science clients across multiple grades of final products and raw materials.
- Analyze client programs and provide meaningful feedback and direction, including recommendations for activity reduction or increase.
- Develop plans for associate monitoring, training, and development.
- Maintain up-to-date knowledge of regulatory requirements and update programs accordingly.
Requirements:
- Thorough understanding of national and international laws, regulations, and guidelines regarding GMP.
- Broad experience in Quality Management, including quality system development, establishment, and maintenance (GXPs).
- Experience in GMP Lab operations, including analytical test methods, equipment usage, software systems, OOS processes, etc.
- Strong resolve and steadfastness in upholding quality standards at external partners and internally.
- Strong leadership skills, ability to work in cross-functional teams, and international environments.
- Demonstrated success in engineering project management and leadership.
- Supplier Quality Engineering experience, including deviation management, change control, equipment qualifications, laboratory controls, process validations, CAPA, risk management tools, batch record review processes, and supplier management.
About SQA Services:
We are committed to empowering our partners with expertise, professionals, and systems to proactively manage supply chain risks, creating safer and more reliable products for end users. SQA Services is an Equal Opportunity Employer, embracing diversity and promoting merit-based employment decisions.
