Senior Manager, Quality Assurance & Regulatory Compliance

Oy Medix Biochemica Ab; Maryland Heights (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Medix Biochemica is seeking a Senior Manager, Quality Assurance and Regulatory Compliance for the St. Louis site.

You will provide strategic leadership for QA and regulatory compliance, maintain the ISO 13485 QMS, and align with global quality strategy while overseeing FDA and USDA registrations. As a key member of Global Quality, you will partner with Manufacturing, Operations, R&D and Product Management to drive a proactive quality culture and continuous improvement, ensuring product quality

Qualifications

• Degree in life sciences, engineering, quality management or related field.
• Extensive QA / regulatory compliance experience in Biologics, IVD materials or biospecimens.
• Fluent English, strong leadership and communication skills.
• Hands-on experience with ISO 13485 and FDA/USDA requirements.

Responsibilities

• Lead and develop the site QA organization and join Global Quality Team.
• Maintain ISO 13485-based QMS and alignment with global quality strategy.
• Oversee FDA/USDA registrations, audits and inspections.
• Provide QA oversight for product release, validation, and documentation.
• Coordinate internal and supplier audits and ensure regulatory compliance.
• Promote lean culture and continuous improvement in manufacturing.
• Collaborate closely with Manufacturing, Operations, and R&D.

Skills

Quality leadership

Audits & CAPA

Lean 5S/6S

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s or Master’s in life sciences / engineering / quality management

Tools

Quality management software

Job description

Medix Biochemica is a global leading company powering the in vitro diagnostics (IVD) industry with mission-critical raw materials. With Finnish roots and operations across Europe, the U.S., and Asia, our teams work at the intersection of science, manufacturing, service and reliability - helping our customers deliver trusted diagnostic results to billions of patients worldwide.

What sets Medix Biochemica apart is not just what we do, but how we do it. We are an independent, science-driven partner focused on quality at scale, supply security, and sustainable technologies. Our global manufacturing footprint and local technical service teams enable us to move quickly, support customers close to where they operate, and build consistency into every product we deliver.

Backed by strong financial resources and a clear long-term strategy, we’ve grown through targeted acquisitions and continued investment in people, capabilities, and infrastructure - all in service of our ambition to be the first-choice partner for mission-critical IVD components. This growth has expanded our portfolio and created new opportunities for collaboration, innovation, and impact across disciplines, and geographies.

Just as we’re committed to enabling reliable diagnostics, we’re equally committed to creating a workplace where people can do meaningful work and grow. Our culture is guided by shared values - We Care, We Dare, and We Deliver -which shape how we work together, challenge ideas, and turn scientific expertise into real-world impact. With over 260 colleagues globally, Medix Biochemica offers the scale of an international organization with the openness, agility, and purpose of a company still building its future.

Role description:

The Senior Manager, Quality Assurance and Regulatory Compliance of St. Louis site provides strategic and operational leadership for Quality Assurance and applicable regulatory compliance at Medix Biochemica’s Ltd operations. The Senior Manager is responsible for the effectiveness, maintenance and continuous improvement of the local ISO 13485-based Quality Management System and for its alignment with Medix Biochemica’s global quality strategy, policies and ways of working. The Senior Manager manages applicable USDA and FDA registrations.

The position acts as the local Quality Management Representative and is a key member of the Global Quality team and the site leadership organization. The Senior Manager works closely with Manufacturing, Operations, Supply Chain, R&D, Product Management, Quality Control and other Medix Biochemica functions.

A central purpose of the role is to build a proactive quality culture in which Quality Assurance works as a close partner to Manufacturing. The Senior Manager promotes lean-thinking, operational discipline, structured problem-solving and continuous improvement while ensuring that product quality and regulatory compliance are maintained.

Key task and responsibilities:

• Implement the global quality and sustainability strategy and objectives across site operations.
• Lead and develop the site Quality Assurance organization and sever as a member of Global Quality Team.
• Act as the local Quality Management Representative and report on QMS and sustainability performance, risks, resource needs and improvement priorities.
• Maintain and continuously improve the ISO 13485-compliant QMS, including document control, training, risk management, deviations, nonconformities, CAPA, change control, complaints, supplier quality and management review.
• Establish and monitor quality objectives, KPIs and improvement actions.
• Work as a close partner to manufacturing to improve process reliability, workplace organization, contamination control, standard work and operational discipline.
• Apply lean and other structured problem-solving methods as part of normal quality work to eliminate waste, simplify processes and improve performance without compromising compliance, product quality or traceability.
• Promote employee involvement and a sustainable culture of continuous improvement.
• Lead QA integration activities related to applicable acquisitions, transferred products, organizational and quality system changes.
• Provide QA oversight for product release, manufacturing documentation, validation, qualification, product development and design transfer.
• Maintain oversight of applicable FDA requirements, USDA permits and inspections; support import permits, customs documentation and export compliance for applicable biological materials.
• Provide QA oversight for the US Human Donor Program, including audits, confidentiality, training and compliance with approved IRB requirements.
• Coordinate internal and supplier audits and host certification, customer and regulatory audits and inspections.
• Oversee customer quality agreements, questionnaires and applicable regulatory declarations.
• Provide compliance oversight of safety and environmental processes while operational ownership remains with the designated Safety Officer and operational management.
• Collaborate with Quality Control on QMS interfaces, investigations, validation and product-quality risks without assuming operational responsibility for QC.

The current US donor procedure assigns St. Louis QA responsibility for control activities and audit coordination, while donor-program operations remain with the Biologicals Team.

Qualifications:

• Bachelor’s or master’s degree in life sciences, engineering, quality management or a related field
• At least eight years of relevant Quality Assurance or regulatory compliance experience in a field of Biological manufacturing, IVD raw materials or biospecimens, including quality leadership experience.
• Strong practical knowledge of ISO 13485 at production environment and applicable FDA requirements.
• Experience with audits, CAPA, change control, risk management, validation, supplier quality and document control.
• Strong collaboration skills and experience working closely with manufacturing and product development.
• Strong analytical, leadership, decision-making and communication skills.
• Professional fluency in written and spoken English.

Experience and skills:

• Demonstrated ability to lead organizational change, QMS harmonization and continuous improvement.
• Comprehensive knowledge about quality management software
• Understanding legislative environment of work and biological safety, human-donor programs and working with animal derived raw materials including exporting activities outside US.
• Practical knowledge of LEAN, 5S/6S or other structured improvement methods.
• Understanding of acquisition integrations and a multicultural work environment