Head of Quality Operations

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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
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