Site Quality & Compliance Leader

PDI - Brand; Orangeburg (NY); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical coverage

401(k) with company match

Life insurance

FSAs

Disability benefits

Employee Assistance Program

Tuition assistance

Paid parental leave

Job summary

PDI is seeking a Senior Manager of Quality & Compliance to lead the site's Quality Management System and drive regulatory readiness for FDA, Health Canada, ISO 13485, EU GMP, and ICH standards. The role partners with cross-functional teams to improve processes, data integrity, and quality metrics while supporting product quality and patient safety across manufacturing operations.

Responsibilities include managing internal and supplier audits, CAPA systems, training, and risk management within a

Qualifications

• Extensive knowledge of pharmaceutical, medical device, and/or cosmetic Quality Management Systems.
• Experience with regulatory inspection management and audit practices.
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies.

Responsibilities

• Provide strategic leadership and governance for the site Quality Management System, ensuring compliance with regulatory requirements and industry standards.
• Collaborate with Manufacturing, Regulatory Affairs, R&D, and Senior Leadership to embed quality into site priorities.
• Lead audits, CAPA, change control, and data integrity programs to ensure inspection readiness and continuous improvement.

Skills

Strategic leadership

Regulatory affairs

Quality management

Risk management

Cross-functional collaboration

Lean Six Sigma

Auditing

Education

Bachelor's degree in scientific discipline

Advanced degree preferred

Tools

eQMS

Job description

PDI is seeking a Senior Manager of Quality & Compliance to lead the site's Quality Management System and drive regulatory readiness for FDA, Health Canada, ISO 13485, EU GMP, and ICH standards. The role partners with cross-functional teams to improve processes, data integrity, and quality metrics while supporting product quality and patient safety across manufacturing operations.

Responsibilities include managing internal and supplier audits, CAPA systems, training, and risk management within a