Quality Operations Leader, Center of Excellence

MilliporeSigma; Danvers (MA); On-site; USD 151,000 - 289,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Danvers, MA seeks a Head of Quality Operations to lead the Quality Organization at the Single-Use Center of Excellence. You will own ISO quality systems, drive CAPA, deviations, changes, and audits, and ensure 24x7 quality operation across materials, processes, and products.

You will partner with manufacturing, R&D, product management, and customer support to elevate quality, data integrity, and continuous improvement, positioning Danvers as a Quality System Center of

Qualifications

• Bachelor’s degree in science, engineering, pharmacy, biotechnology, microbiology, chemistry, or related discipline.
• 7+ years of experience in quality management and quality systems in life sciences/biopharma/medical devices.
• Experience leading a quality organization and overseeing quality processes including product development, regulatory compliance, supplier quality, validations, and product release.
• Ability to drive strategy, prioritization, and direction within life science industry.
• Experience coordinating with manufacturing, R&D, and product development to meet quality standards.
• Excellent written and verbal communication skills; able to influence across departments.
• Onsite presence required; reside within commuting distance.

Responsibilities

• Develop and lead the Quality Organization at the Danvers site.
• Ensure compliance of the Danvers Quality System to ISO 9001-2015, ISO 14001-2015, and related procedures.
• Own CAPA, deviation, change control, and audits; drive improvements and operational excellence.
• Support customer satisfaction through handling visits, complaints, inquiries, and field actions.
• Collaborate with corporate quality, product management, and customer support teams to solve problems.
• Oversee 24x7 operations ensuring material, process, and product quality; manage supplier audits and corrective actions.
• Oversee document control, incoming inspection, product release testing, and QA release activities.
• Lead Quality Engineering, validation support, and master planning for new products.
• Position Danvers as a Quality System Center of Excellence within the network.
• Ensure regulatory compliance for current and future markets; drive Data integrity and digitization initiatives.
• Lead monthly, quarterly, and annual quality reviews.

Skills

Quality leadership

Project management

Communication skills

Cross-functional collaboration

Strategic thinking

Change management

Regulatory understanding

Onsite presence

Education

Bachelor’s degree in science/engineering

Tools

Electronic Quality Management System

Job description

MilliporeSigma in Danvers, MA seeks a Head of Quality Operations to lead the Quality Organization at the Single-Use Center of Excellence. You will own ISO quality systems, drive CAPA, deviations, changes, and audits, and ensure 24x7 quality operation across materials, processes, and products.

You will partner with manufacturing, R&D, product management, and customer support to elevate quality, data integrity, and continuous improvement, positioning Danvers as a Quality System Center of