Quality Assurance Manager
SSI Diagnostica Group
Summary
Join our team at the TechLab site, part of the SSI Diagnostica Group, as a Quality Assurance Manager and help shape the future of healthcare technology. We are seeking multiple candidates that are experienced leaders to oversee critical projects in the medical device industry.
Job description
The Opportunity
The job of Quality Assurance Manager entails the direct supervision of all Quality Assurance and Document Control personnel. The Quality Assurance Manager will be responsible for the maintenance of the quality system as well as maintaining compliance with regulatory requirements. The Quality Assurance Manager will report to the Vice President of Global Quality Assurance and oversees Document Control and Quality Assurance Supervisors, Officers and Assistants.
Key Responsibilities
- Ensure compliance of the Quality Management System to all global regulatory requirements.
- Local implementation of global initiatives for compliance and process improvements
- Management of local Quality Assurance Team
- Duties for Quality Management Representative within local Quality Management System and to report state to management
- Oversight of releasing raw materials, components and finished products lots
- Ensure Non-Conformities and Corrective and Preventive Actions are identified, investigated, and controlled
- Ensure company Training requirements/competencies are documented and current
- Oversight of Document Control Program
- Oversight of Validation Program
- Oversight of the Stability Program
- Oversight of Supplier Management
- Providing information/documentation to support Annual Management Review
- Hosting internal and external audits
Qualifications and Experience
- B.A. or B.S. in a life sciences + 10 years of experience with 3 years supervisory experience in GMP/QSR environment.
- Strong track record of developing and implementing QMS frameworks in regulated industries.
- Excellent leadership, communication, and collaboration skills; proven ability to influence across functional boundaries.
- Experience effectively managing and motivating resources to attain company and team goals.
- In-depth knowledge of Quality Management Systems (QMS) and relevant industry regulations.
- Background in continuous improvement with demonstrated results in cross functional collaboration
- Ability to analyze complex quality issues, identify root causes, and implement effective corrective actions.
- Proven ability to handle and resolve quality-related challenges in a dynamic research and manufacturing environment.
Location and Work Policy
TechLab maintains a climate-controlled environment for the job of Quality Assurance Manager. A typical workday is Monday through Friday 8:00 to 4:30 or 8:30 to 5:00. Overtime is occasionally necessary with or without advance notice.
Requirements
- B.A. or B.S. in a life sciences
- 10 years of experience
- 3 years supervisory experience in GMP/QSR environment
- Strong track record of developing and implementing QMS frameworks in regulated industries
- Excellent leadership, communication, and collaboration skills
- Proven ability to influence across functional boundaries
- Experience managing and motivating resources to attain company and team goals
- In-depth knowledge of Quality Management Systems (QMS) and relevant industry regulations
- Background in continuous improvement with demonstrated results in cross functional collaboration
- Ability to analyze complex quality issues, identify root causes, and implement effective corrective actions
- Proven ability to handle and resolve quality-related challenges in a dynamic research and manufacturing environment
Company overview
SSI Diagnostica Group is a global leader in infectious disease clinical diagnostics, originally established as a division of the prestigious Danish National Reference Center – Statens Serum Institut. Founded in 1902 and currently owned by Adelis Equity, the company has grown significantly with headquarters in Hillerød, Denmark, employing over 600 people worldwide. The group specializes in innovative solutions for disease surveillance, diagnosis, outbreak investigation, and quality control across three key therapeutic areas: gastrointestinal, respiratory, and bloodborne diseases. SSI Diagnostica Group operates as a consolidated entity resulting from strategic acquisitions of five complementary companies – SSI Diagnostica, TECHLAB, Beijing Genesee Biotech, CTK Biotech, and Gulf Coast Scientific – bringing together more than 200 years of combined scientific expertise. The company develops, manufactures, and markets state-of-the-art IVD diagnostic kits and consumables including culture media, lateral flow tests, EIA & ELISA platforms that deliver fast and reliable results trusted by clinicians globally. With administrative and manufacturing facilities in Denmark, the United States, and China, and products distributed in over 130 countries, SSI Diagnostica Group serves approximately 60 million patients annually, empowering healthcare professionals to enable better treatment outcomes through accurate infectious disease diagnostics.