Head of Quality Operations

Merck•Danvers, MA

2d•$150,500 - $288,500•Onsite

About The Position

The Head of Quality Operations will develop and lead the Quality Organization at MilliporeSigma’s Single-Use Center of Excellence in Danvers, Massachusetts. The role owns the site’s Quality System and ensures compliance with ISO 9001-2015, ISO 14001-2015, applicable corporate procedures, regulatory requirements, and requirements for products in their intended markets. The role also positions the Danvers site as the Quality System Center of Excellence and aligns its system with other Mobius Single-Use facilities in the network. The position leads quality operations supporting 24/7 manufacturing, including incoming inspection, product lot release testing, cleanroom environmental monitoring, document control, and QA release. It oversees supplier audits and corrective actions, Quality Engineering, site validation support, the Validation Master Plan, and new product design assurance. The Head of Quality Operations drives Quality System improvements and operational excellence across CAPA, deviations, change control, audits, customer satisfaction, and strategic initiatives such as data integrity, Quality Culture, continuous improvement, and digitization. The role leads monthly, quarterly, and annual Quality reviews and collaborates with plant, corporate, product management, quality services, and customer support stakeholders. The position is onsite and requires residence within commuting distance of the workplace. The role does not offer work-authorization sponsorship; external applicants must be eligible to work in the United States. Base pay is listed at $150,500–$288,500, with possible eligibility for sales or performance-based bonuses. Company benefits include health insurance, paid time off, retirement contributions, and other perquisites.

Requirements

Bachelor’s degree in science, engineering, pharmacy, biotechnology, microbiology, chemistry, or a related discipline.
At least 7 years of work experience, including at least 5 years in quality management and quality systems in the life science, biopharmaceutical, or medical device industry.
Demonstrated experience leading a site- or business-level quality organization overseeing product development quality processes, customer audits, regulatory compliance, quality management systems, complaint investigations, supplier quality, validations, and product release.
Demonstrated project-management and improvement-plan experience, including providing strategy, priorities, and direction in the life science industry.
Ability to interpret government regulations, customer needs, and business needs and translate them into programs, policies, and procedures that ensure products and services meet established quality standards.
Experience working with manufacturing, technical operations, R&D, and product development processes in a pharmaceutical, biotech, food and beverage, chemical, medical device, or life science industry.
Outstanding written and presentation communication skills.
Ability to lead through complexity, influence without direct authority, and make decisions involving business, technical, and compliance trade-offs.
Must reside within commuting distance of the workplace and be able to work onsite.
External applicants must be eligible to work in the United States; the role does not offer work-authorization sponsorship.

Nice To Haves

At least 10 years of work experience, including 7 years in quality management and quality systems in the life science, biopharmaceutical, or medical device industry.
Quality operations experience in pharmaceutical or biopharmaceutical companies, including regulatory-body inspections such as FDA inspections.
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.
Master of Business Administration degree.

Responsibilities

Develop and lead the Quality Organization at the Danvers Single-Use Center of Excellence.
Own compliance of the Danvers Quality System with ISO 9001-2015, ISO 14001-2015, and applicable corporate and regulatory quality procedures; assess gaps and implement remediation.
Drive improvements and operational excellence in the Quality System, including CAPA, deviations, change control, and internal, supplier, and customer audits.
Support customer satisfaction through technical visits, complaint management, customer inquiries, change notifications, and field corrective actions.
Collaborate with corporate quality, quality services, product management, and customer support to foster problem solving.
Support 24/7 operations by ensuring incoming raw materials, processes, and outgoing products meet quality requirements and specifications.
Oversee supplier audits and corrective actions to remediate raw material issues.
Ensure 24/7 Quality Operations, including document control, incoming inspection, product lot release testing, cleanroom environmental monitoring, and QA release.
Own and oversee Quality Engineering, including site validation support, the Validation Master Plan, and new product design assurance.
Position the Danvers manufacturing site as the Quality System Center of Excellence and align its Quality System with other Mobius Single-Use facilities.
Ensure existing and new products comply with current and future regulations in their intended markets.
Work with plant and corporate stakeholders to own and drive strategic business and quality initiatives, including data integrity, Quality Culture, continuous improvement, and digitization.
Lead and own monthly, quarterly, and annual Quality reviews.