Senior Manager, Quality Assurance

Veranex, Inc. • Atlanta, GA

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About The Position

The Senior Manager, Quality Assurance provides leadership and support to the quality assurance team and is responsible for ensuring applicable standards, regulations, and guidelines are followed for development products. The role collaborates with internal and external cross-functional teams to evaluate processes, procedures, and activities for compliance with industry standards, regulatory guidelines, and company SOPs. Depending on location, the role may also include Quality, Health, Safety, and Environment (QHSE) and Regulatory Compliance (RC) responsibilities.

Requirements

• Bachelor's degree in a science-related discipline.
• 7–10 years of experience in the health care field, preferably with medical device experience.
• Solid, demonstrable understanding of FDA regulations, including 21 CFR Parts 820, 11, and 58, and ISO standards including 13485, 9001, 14971, and 14155.

Nice To Haves

• Experience hosting audits with major medical device manufacturers, government agencies (FDA, USDA, DEA, DOD), AAALAC, and notified bodies or registrars.
• Experience with MasterControl or a similar quality system.
• Experience with OECD regulations.

Responsibilities

• Develop processes and procedures to maintain compliance with FDA regulations.
• Lead internal and external audits involving clients, vendors, regulatory bodies, and government agencies.
• Monitor regulatory agency trends and proactively support inspection readiness and high-quality results for sponsors and clients.
• Assess the impact of changes on the organization's quality system and work with executive sponsors and relevant leadership to implement key changes.
• Communicate regulatory updates to executive leadership and other relevant stakeholders.
• Provide vendor oversight to ensure compliance with applicable standards, regulations, and quality system requirements.
• Define organizational quality goals and strategic initiatives and work with executive leadership to achieve them.
• Conduct functional area reviews to assess organizational quality risks.
• Manage CAPA processes and ensure timely execution of all phases.
• Advise on other quality systems, including equipment, calibration, and preventive maintenance.
• Deploy relevant staff training, including ad hoc and annual training.
• Establish and compile metrics related to quality system areas.
• Identify and oversee continual improvement efforts.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior