Global QA Director, Bioservices

Precisionmedicinegroup; Frederick (MD); On-site; USD 162,000 - 243,000; Full time

Job summary

Precision Medicine Group in the United States is seeking a Director of Quality Assurance (Bioservices) to lead global quality systems, oversee laboratories, supplier qualification, and clinical trials, and ensure compliance with FDA QSR, IVDR/IVDD, ISO 13485 and ISO 15189.

You will plan resources, drive process improvements, guide cross-functional teams, and prepare for regulatory assessments, while supporting post-market surveillance and design controls for diagnostic products.

Qualifications

• Bachelor’s degree in physical, Biological Sciences, or technical/scientific field.
• 10-12 years’ experience in a Quality driven life science, regulated environment.
• 5 years of supervisory experience.
• Relevant Industry Certification(s).

Responsibilities

• Plan and direct resources and activities of the quality and compliance functions across all facilities globally.
• Provide oversight to site specific quality leadership team.
• Identify/lead and participate in process improvement initiatives and align global quality systems.
• Provide updates to company leadership regarding status of quality system and performance.
• Collaborate with cross-functional operational and quality staff in other Precision locations globally.
• Oversee global Quality Management Systems supporting laboratories, supplier qualification, and clinical trials.
• Support regulatory functions related to FDA QSR, IVDD/IVDR, ISO 13485 and ISO 15189.
• Release of all products manufactured and results released from commercial diagnostic products.
• Lead external regulatory agency, client and notified body assessments and inspections.
• Serve as Management Representative designee for periodic management reviews.

Education

Bachelor’s degree in physical, Biological Sciences, or technical/scientific field

Job description

Precision Medicine Group in the United States is seeking a Director of Quality Assurance (Bioservices) to lead global quality systems, oversee laboratories, supplier qualification, and clinical trials, and ensure compliance with FDA QSR, IVDR/IVDD, ISO 13485 and ISO 15189.

You will plan resources, drive process improvements, guide cross-functional teams, and prepare for regulatory assessments, while supporting post-market surveillance and design controls for diagnostic products.