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

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!