Head of Quality Operations

The businesses of Merck KGaA, Darmstadt, Germany•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 has overall ownership of the Danvers Quality System, ensuring compliance with ISO 9001-2015, ISO 14001-2015, and applicable corporate and regulatory quality procedures. The position assesses compliance gaps, implements remediation, and drives improvements and operational excellence across the Quality System. The role supports customer satisfaction through technical visits, complaint management, inquiries, change notifications, and field corrective actions, while collaborating with corporate quality, quality services, product management, and customer support. It supports 24 x 7 operations by ensuring raw materials, processes, and products meet requirements, and oversees supplier audits and corrective actions. Quality Operations include document control, incoming inspection, lot-release testing, cleanroom environmental monitoring, and QA release. The Head of Quality Operations also oversees Quality Engineering, including site validation support, the Validation Master Plan, and new-product design assurance. The position leads the Danvers site’s development as a Quality System Center of Excellence, aligns its system with other Mobius Single-Use facilities, ensures regulatory compliance for current and future markets, leads strategic quality and business initiatives, and owns monthly, quarterly, and annual Quality reviews. The role requires onsite presence and residence within commuting distance of the workplace.

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.
Experience leading a site- or business-level quality organization and overseeing quality processes related to product development, customer audits, regulatory compliance, quality management systems, complaint investigations, supplier quality, validations, and product release.
Demonstrated project-management experience and/or experience driving improvement plans, including providing strategy, priorities, and direction within 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 in pharmaceutical, biotech, food and beverage, chemical, medical-device, or life-science industries.
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.
Must be eligible to work in the United States; the role does not offer work-authorization sponsorship.

Nice To Haves

10 or more 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, 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 compliance gaps and implement remediation measures.
Drive improvements and operational excellence in the Quality System, including CAPA, deviations, change control, and internal, supplier, and customer audits.
Support and lead customer-facing activities, including 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 x 7 operations by ensuring incoming raw materials, processes, and outgoing products meet or exceed quality requirements and specifications.
Oversee supplier-related audits and corrective actions to remediate raw-material issues.
Ensure 24 x 7 Quality Operations, including document control, incoming inspection, product lot-release testing, cleanroom environmental monitoring, and QA release activities.
Oversee Quality Engineering functions, including site validation support, the Validation Master Plan, and new-product design assurance.
Lead the Danvers site’s positioning 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.
Lead strategic business and quality initiatives with plant and corporate stakeholders, including data integrity, Quality Culture, continuous improvement, and digitization.
Lead and own monthly, quarterly, and annual Quality reviews.