Senior Director of Quality Systems & Compliance

About the role

For our client, we are seeking a Senior Director of Quality Systems & Compliance to join the team of a leader in the Healthcare space. This leader will drive the quality systems and compliance strategy for a healthcare organization operating in a highly regulated environment. The role will partner closely with leadership, operations, suppliers, and external stakeholders to strengthen product quality, regulatory adherence, and customer confidence. It will also oversee core quality system processes and help ensure the organization’s products and practices meet applicable standards across the business.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead strategic planning for quality teams to meet compliance and quality standards
• Guide teams in developing product specifications for branded products
• Support suppliers and partners in implementing quality assurance programs
• Ensure compliance with FDA and ISO regulations through regular audits
• Liaise with leadership and operational teams to uphold product quality and customer satisfaction
• Oversee the design and implementation of the Quality System across the organization
• Manage key quality system processes, including CAPA and recall management

Qualifications

• Bachelor’s degree in Engineering, Science, or a technical field
• 8+ years of experience in pharmaceutical design and manufacturing, including compliance with QSR, GMP, and ISO requirements
• 5+ years of management experience
• Experience with medical device regulations is preferred
• Strong capability in developing strategic plans aligned with business needs

Benefits

• Competitive total rewards package
• Continuing education and training opportunities
• Health insurance and disability coverage
• 401(k) contributions
• Paid time off
• Access to Employee Assistance Program and Employee Resource Groups

Pay

$203,000 – $305,000 annually