Surgenex seeks to add a full time Director of Quality and Regulatory Affairs to our growing team.
Responsible for setting and executing short- and long-term goals and objected related to quality assurance, quality control and regulatory affairs.
Establish, implement, and maintain systems, policies, and procedures to ensure compliance with all relevant regulations and standards set forth by the FDA, AATB, and other state, local, and international regulatory bodies.
Oversee and maintain licensing, registration, and accreditation with relevant regulatory bodies.
Host and lead federal, state, and other accrediting bodies in regulatory audits and inspections.
Oversees the day-to-day activities related to the quality and safety of tissue products.
Perform complaint and non-conformance investigations, root-cause analysis, and other problem-solving activities to identify effective corrective actions and process improvements.
Oversees the review and approval of product and manufacturing quality controls and changes for adherence to quality system requirements.
Establish, implement, and oversee core quality programs included: CAPAs, non-conformances, complaint investigation, employee training and competency assessment, document control, facilities and equipment control, vendor qualification and supplier audit, materials control, internal audits.
Maintain excellent judgment and decision-making capabilities to formulate quality solutions related to company mission and objectives.
Provides quality expertise, advice and/or assistance across the organization as required.
Bachelors degree, advanced degree preferred
10 years experience in FDA regulated environment
5 years management experience
Previous experience in GMP manufacturing
CTBS and previous tissue banking experience preferred
Internal Number: 527
Surgenex® is an industry leading provider of regenerative medicine solutions setting the standard in quality and safety. We are committed to addressing unmet patient needs by developing, producing and distributing the highest quality allografts in the industry.