Global Quality Director, Bioprocess & Compliance

Repligen Corporation; Waltham (MA); Hybrid; USD 191,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Job summary

Repligen seeks a Senior Director, Quality to lead global QA across Filtration & System networks, ensuring regulatory compliance, robust quality systems, and customer satisfaction. You will drive strategic quality initiatives, partner with Operations, Regulatory, and Commercial, and build a high-performing team across locations.

You will oversee audits, supplier quality, change management, and continuous improvement programs within ISO 9001/13485 environments, guiding quality excellence worldwide.

Qualifications

• 15+ years of quality leadership experience in regulated manufacturing industries
• 5+ years leading a quality organization (QA, QC, Compliance, and Systems)
• 7+ years of people leadership and team development
• Experience leading customer and certification audits with regulatory authorities
• Thorough knowledge of ISO 9001; ISO 13485 and GMP knowledge desirable

Responsibilities

• Lead quality strategy across global networks, with QA, Systems, Compliance, Validation, and Customer Quality activities
• Ensure compliance with policies, ISO requirements, regulations, and customer expectations across all sites
• Lead audits with customers and regulators and interactions with authorities
• Develop and harmonize quality systems, processes, and procedures for product quality and reliability
• Collaborate with Commercial, Operations, Product Management, Supply Chain and Regulatory to manage customer quality agreements and changes
• Establish and monitor quality metrics to drive continuous improvement
• Build and mentor a high-performing quality organization across sites
• Represent Quality on cross-functional projects and leadership forums

Skills

Quality leadership

Regulatory knowledge

Audits

Cross-functional collaboration

Education

Bachelor’s degree in science, engineering, life sciences, or related field

Job description

Repligen seeks a Senior Director, Quality to lead global QA across Filtration & System networks, ensuring regulatory compliance, robust quality systems, and customer satisfaction. You will drive strategic quality initiatives, partner with Operations, Regulatory, and Commercial, and build a high-performing team across locations.

You will oversee audits, supplier quality, change management, and continuous improvement programs within ISO 9001/13485 environments, guiding quality excellence worldwide.