Senior Manager, Quality Assurance

Veranex; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Veranex is seeking a Senior Manager of Quality Assurance in the United States to lead the QA team, ensure compliance with FDA regulations, and drive continuous improvement across the quality system. The role involves coordinating audits, CAPA processes, and supplier oversight to maintain the highest standards for our development products.

You will collaborate with cross-functional teams, monitor regulatory changes, and implement strategic initiatives to improve quality metrics and inspection

Qualifications

• Bachelor's degree in a science discipline required.
• 7–10 years in healthcare field, preferably with medical device experience.
• Strong, demonstrated understanding of FDA regulations.

Responsibilities

• Develop processes to maintain FDA compliance.
• Lead internal and external audits.
• Monitor regulatory trends and ensure inspection readiness and high-quality results.
• Collaborate with Testing Facility Management and Institutional Official to drive quality changes.
• Communicate regulatory updates to relevant stakeholders.
• Provide vendor oversight to ensure compliance.

Skills

FDA Regulations

QA Leadership

Audit Management

CAPA Management

Training & Docs

Education

Bachelor's degree in science

Tools

MasterControl

Quality Management System

Job description

About This Role:

The experienced Senior Manager, Quality Assurance (QA) provides leadership and support to the quality assurance team. Responsible for applicable standards, regulations and guidelines in compliance for development products. This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate. Depending on the location, Quality, Health, Safety, and Environment (QHSE) and Regulatory Compliance (RC) responsibilities may be included.

What You Will Do:

• Develop processes and procedures to maintain compliance with FDA regulations.
• Lead internal and external audits
• Monitoring current trends of regulatory agencies and deliver proactive approach to ensure inspection readiness and high quality results to Sponsors.
• Understanding the impact of changes on the organizations’ quality system and working with Testing Facility Management (TFM) and the Institutional Official (IO) to drive change.
• Communicating regulatory updates (especially to TFM and IO).
• Providing vendor oversight to ensure compliance.
• Defining quality goals and strategic initiatives for the organization and working with TFM to achieve them.
• Conducting functional area review to provide TFM with assessment of organizational risk to quality.
• Lead FDA audits and other authorities and client audits as needed.
• Manage CAPA processes and ensure timely execution of all phases.
• Advise other quality systems such as equipment, calibration, preventive maintenance.
• Oversee document control group and training requirements with timely execution.
• Deploy relevant training to staff.
• Responsible for establishing and compiling metrics related to quality system areas.
• Identify and oversee continual improvement efforts.

Qualifications:

Required skills:

• Bachelor's Degree in a science related discipline
• 7-10 years’ experience in health care field preferably with medical deviceexperience
• Solid, demonstrable understanding of FDA regulations

Highly Preferred:

• Experience hosting audits with major medical device manufacturers and government agencies (USDA, DEA, DOD)
• Experience with Master Control or similar quality system
• Experience with OECD regulations