Strategic QA & Compliance Leader – Life Sciences

PDI; Orangeburg (NY); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical coverage

401(k) with company match

Life insurance

Job summary

PDI is seeking a Senior Manager of Quality & Compliance to lead the site Quality Management System, ensure regulatory readiness, and drive continuous improvement across FDA, Health Canada, ISO 13485, and EU GMP standards. You will oversee audits, CAPA, data integrity, and supplier quality while partnering with cross-functional teams to safeguard product quality and patient safety.

The role requires 10+ years in quality roles within life sciences, strong leadership, and a track record of

Qualifications

• 10+ years in Quality Assurance, Quality Systems, and Compliance in a life sciences tech setting.
• Leadership experience managing Quality Systems, Compliance, or QA teams.
• Experience leading regulatory inspections and audits with FDA/Health Canada and other agencies.
• ASQ CMQ/OE or CQA preferred; Lean/Six Sigma know-how is a plus.

Responsibilities

• Provide strategic leadership for the site Quality Management System and governance.
• Develop and maintain quality policies, procedures, and governance processes.
• Collaborate with Manufacturing, Regulatory, R&D, and Leadership to integrate quality objectives.
• Lead audits, CAPA, Change Control, and data integrity efforts.
• Drive QMS improvements, regulatory inspection readiness, and training initiatives.
• Mentor and develop Quality personnel and sustain inspection readiness.

Skills

Quality leadership

Regulatory knowledge

Audits & inspections

Risk management

Cross-functional collaboration

Education

Bachelor's degree in science

Advanced degree preferred

Tools

eQMS

Job description

PDI is seeking a Senior Manager of Quality & Compliance to lead the site Quality Management System, ensure regulatory readiness, and drive continuous improvement across FDA, Health Canada, ISO 13485, and EU GMP standards. You will oversee audits, CAPA, data integrity, and supplier quality while partnering with cross-functional teams to safeguard product quality and patient safety.

The role requires 10+ years in quality roles within life sciences, strong leadership, and a track record of