Head of Quality Operations

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

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Head of Quality Operations will develop and lead the Quality Organization at MilliporeSigma’s Single-Use Center of Excellence located in Danvers, Massachusetts. Specifically, the Head of Quality Operations will be responsible for:

• Taking overall ownership of ensuring compliance of the Danvers Quality System to ISO 9001-2015, ISO 14001-2015 and applicable corporate and regulatory quality procedures;
• Assessing gaps and implementing remediation measures as needed to ensure compliance;
• Owning and driving improvements and operational excellence to the Quality System management including CAPA, deviation, change control, and audits (internal, supplier, customer);
• Driving customer satisfaction by supporting and leading activities such as technical visits, customer complaints management, customer inquiries, change notification, and field corrective action;
• Working with corporate quality, quality services, product management and customer support functions to foster collaborative problem solving;
• Supporting 24 x 7 operations by ensuring incoming raw material, process and outgoing product meet or exceed quality requirements, expectations and specifications. Overseeing and driving supplier-related audits and corrective actions to remediate raw material issues;
• Ensuring 24x7 Quality Operations including document control, incoming inspection, product lot release testing, cleanroom environmental monitoring and QA release activities;
• Owning and overseeing Quality Engineering functions including site validation support, Validation master plan and new product design assurance;
• Leading the positioning of the Danvers manufacturing site as the Quality System Center of Excellence, ensuring alignment of the Quality System with other Mobius Single-Use facilities in the network;
• Ensuring that all existing and new products are compliant with existing regulations and any future regulations for the respective markets they are intended for;
• Working with plant and corporate stakeholders to own and drive key strategic business and quality initiatives, including but not limited to Data integrity, Quality Culture, Continuous Improvement and Digitization; and
• Leading and own the Monthly, Quarterly and Annual Quality reviews.

Who You Are

Minimum Qualifications

• Bachelor’s degree in science, engineering, pharmacy, biotechnology, microbiology, chemistry, or a related discipline;
• 7+ years of working experience, with minimum 5 years in quality management and quality systems in the life science, biopharmaceutical, or medical device industry;
• Demonstrated experience leading a quality organization at a site or business level overseeing all aspects of quality, including quality processes as it relates to product development, customer audits, regulatory compliance, quality management systems, complaint investigations, supplier quality, validations and product release
• Demonstrated ability in project management and/or driving improvement plans, including the ability to provide strategy, priority, and direction within life science industry
• Demonstrated ability with government regulations, customer needs, and business needs and demonstrated ability to translate those needs into programs, policies, and procedures that ensure products and services meet established quality standards
• Demonstrated ability working with all areas of manufacturing, technical operations, R&D, and product development process in pharmaceutical, biotech, food & beverage, chemical, medical devices, or life science industry
• Outstanding communication skills, both in writing and presentations.
• Proven ability to lead through complexity, influence without direct authority, and make decisions in situations involving business, technical, and compliance trade-offs.
• Onsite presence is also required, so the individual must reside within commuting distance of the workplace.

Preferred Qualifications

• 10+ years of working experience, with 7 years in quality management and quality systems in the life science, biopharmaceutical, or medical device industry;
• Work experience in quality operations for pharmaceutical / biopharmaceutical companies, including inspections from regulatory bodies such as FDA.
• Knowledge of sterilization, aseptic processing interfaces, bioburden and endotoxin control, particulate control, extractables and leachables, and material compatibility.
• Experience with products or processes involving single-use technologies, polymeric components, tubing, connectors, molded parts, bags, assemblies, or other disposable manufacturing technologies.
• Familiarity with electronic quality management systems and data-integrity expectations.
• Experience managing quality performance across multiple shifts, production areas, multiple sites or international stakeholders.
• Masters of Business Administration degree.
• All years of experience may be gained concurrently.

Pay Range for this position: $150,500 - $288,500

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!