Senior Manager, Quality Assurance

About This Role:

The experiencedSenior 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 including be not limited to clients, vendors, regulatory bodies and government agencies
• Monitoring current trends of regulatory agencies and deliver proactive approach to ensure inspection readiness and high quality results to Sponsors and clients
• Understanding the impact of changes on the organizations’ quality system and working with executive sponsors and other relevant leadership in the organization to drive key changes
• Communicating regulatory updates to executive leadership and other relevant stakeholders
• Providing vendor oversight to ensure compliance to applicable standards and regulations.
• Defining quality goals and strategic initiatives for the organization and working with executive leadership to achieve them.
• Conducting functional area review to provide assessments of organizational risk to quality and Veranex
• Providing vendor oversight to ensure quality system compliance in accordance with regulations, standards and company policy
• Manage CAPA processes and ensure timely execution of all phases.
• Advise other quality systems such as equipment, calibration, preventive maintenance.
• Deploy relevant training to staff including ad hoc and annual
• 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 device experience
• Solid, demonstrable understanding of FDA regulations such as 21 CFR Part 820, Part 11, Part 58 and ISO standards including 13485, 9001, 14971, 14155, etc.

Highly Preferred:

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