Heads of Quality Operations

Posted 13 Jan 2023

Danvers, Massachusetts - United States

Req Id 260260

 

Work Your Magic with us!

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. 


Job Title: Heads of Quality Operations

 

Job Location: 17 Cherry Hill Drive, Danvers, MA 01923

 

Job Responsibilities:

 

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:

 

  1. 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;
  2. Assessing gaps and implementing remediation measures as needed to ensure compliance;
  3. Owning and driving improvements and operational excellence to the Quality System management including CAPA, deviation, change control, and audits (internal, supplier, customer);
  4. Driving customer satisfaction by supporting and leading activities such as technical visits, customer complaints management, customer inquiries, change notification, and field corrective action;
  5. Working with corporate quality, quality services, product management and customer support functions to foster collaborative problem solving;
  6. 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;
  7. Ensuring 24x7 Quality Operations including document control, incoming inspection, product lot release testing, cleanroom environmental monitoring and QA release activities;
  8. Owning and overseeing Quality Engineering functions including site validation support, Validation master plan and new product design assurance;
  9. Leading the positioning of the Danvers manufacturing site as the Quality System Center of Excellence ensuring central control of the Quality System at the Mobius Single-Use manufacturing facility in Wuxi, China and Molsheim, France;
  10. Ensuring that all existing and new products are compliant with existing regulations and any future regulations for the respective markets they are intended for;
  11. 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
  12. Leading and own the Monthly, Quarterly and Annual Quality reviews.

 

Job Requirements:

Employer requires a bachelor’s degree in an engineering or science field.  Employer also requires five (5) years of progressively more responsible work experience in quality management and quality systems in the life science, biopharmaceutical, or medical device industry.  Candidate must also have:

 

  1. Demonstrated ability in project management including the ability to provide strategy, priority, and direction within life science industry gained through at least 5 years of work experience;
  2. Demonstrated ability leading a quality organization at a site or business level overseeing all aspects of quality including quality processes as it relates to product development, regulatory compliance, quality management systems, investigations, supplier quality, validations and product release gained through at least 5 years of work experience;
  3. 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 gained through at least 5 years of work experience; and
  4. 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 gained through at least 5 years of work experience.

 

All years of experience may be gained concurrently.

 

Telecommuting is available but onsite presence is also required, so the individual must reside within commuting distance of the work place.

 

10% domestic and 10% international travel per year required.

 

This position is eligible for EMD Millipore’s Employee Referral Program.

 

Applicants can mail resumes to EMD Millipore Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 260260) or apply online at https://www.emdgroup.com/en/company.html



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html


Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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