Quality Assurance Manager (GMP)

Posted 15 Feb 2024

Miamisburg, Ohio - United States

Req Id 271163

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.  

 

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. 

 


Your Role:

MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager.  As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies. 

Responsibilities:

  • Provide leadership and expertise on quality assurance processes and tools
  • Lead a team that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Audits, Complaint Management, Supplier Quality, Document Control, Validation, and Data Integrity
  • Ensure that departments responsible for products meet quality standards and performance goals of MilliporeSigma
  • Ensure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems
  • Support the site’s compliance activities through accurate regulatory recordkeeping and reporting
  • Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMP
  • Hire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goals
  • Drive achievement of site vision and goals / objectives
  • Drive risk reduction programs and ensure application of risk management and sound root cause analysis
  • Analyze and report quality measures, performance, tends and improvements
  • Review and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure compliance
  • Provide quality assurance support to other site departments
  • Support the site’s regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.

  

Who You Are: 

Minimum Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or other Science field 
  • 3+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry
  • 2+ years of experience in a leadership position

 

Preferred Qualifications:

  • 5+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry
  • 3+ years of experience with progressing increasing responsibilities as a supervisor
  • Experience with quality management systems such as Trackwise, electronic document management system, etc.
  • Experience with customer audits and regulatory inspections


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


US 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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, 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.


Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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