Senior Manager, Quality Assurance

Veranex•Raleigh, NC

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 cross-functional internal and external teams to evaluate processes, procedures, and activities for compliance with relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (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.
Demonstrable understanding of FDA regulations, including 21 CFR Part 820, Part 11, and Part 58.
Demonstrable understanding of ISO standards, including 13485, 9001, 14971, and 14155.

Nice To Haves

Experience hosting audits with major medical device manufacturers and government agencies, including FDA, USDA, DEA, and DOD, as well as AAALAC and notified bodies/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, including audits involving clients, vendors, regulatory bodies, and government agencies.
Monitor regulatory agency trends and take a proactive approach to maintain inspection readiness and deliver high-quality results to sponsors and clients.
Assess the impact of changes on the organization's quality system and work with executive sponsors and other relevant leaders to implement key changes.
Communicate regulatory updates to executive leadership and 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 and risks to Veranex.
Manage CAPA processes and ensure timely execution of all phases.
Advise on other quality systems, including equipment, calibration, and preventive maintenance.
Deliver relevant training to staff, including ad hoc and annual training.
Establish and compile metrics related to quality system areas.
Identify and oversee continual improvement efforts.