Senior Manager, Quality Assurance & Regulatory Compliance

Medix Biochemica•Maryland Heights, MO

About The Position

The Senior Manager, Quality Assurance and Regulatory Compliance for the St. Louis site provides strategic and operational leadership for Quality Assurance and applicable regulatory compliance at Medix Biochemica’s operations. The role is accountable for the effectiveness, maintenance, and continuous improvement of the local ISO 13485-based Quality Management System (QMS), and for aligning it with the company’s global quality strategy, policies, and ways of working. The Senior Manager manages applicable USDA and FDA registrations. The role serves as the local Quality Management Representative and is a member of both the Global Quality team and the site leadership organization. It works closely with Manufacturing, Operations, Supply Chain, R&D, Product Management, Quality Control, and other company functions. A central purpose is to build a proactive quality culture in which QA partners closely with Manufacturing, promoting lean thinking, operational discipline, structured problem-solving, and continuous improvement while maintaining product quality and regulatory compliance.

Requirements

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 biological manufacturing, IVD raw materials, or biospecimens, including quality leadership experience.
Strong practical knowledge of ISO 13485 in a 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.
Demonstrated ability to lead organizational change, QMS harmonization, and continuous improvement.
Comprehensive knowledge of quality management software.
Understanding of the legislative environment and biological safety, human-donor programs, and work with animal-derived raw materials, including exports outside the US.

Nice To Haves

Practical knowledge of LEAN, 5S/6S, or other structured improvement methods.
Understanding of acquisition integrations and multicultural work environments.

Responsibilities

Implement the global quality and sustainability strategy and objectives across site operations.
Lead and develop the site Quality Assurance organization and serve as a member of the 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.
Partner with Manufacturing to improve process reliability, workplace organization, contamination control, standard work, and operational discipline.
Apply lean and other structured problem-solving methods 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 acquisitions, transferred products, organizational changes, 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.
Carry out St. Louis QA responsibility for control activities and audit coordination under the current US donor procedure; donor-program operations remain with the Biologicals Team.