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:

Provides Quality Assurance leadership to the organization relative to product quality issues, new product introductions, and quality improvement opportunities for products and/or clients assigned. Acts as Quality System expert to the organization regarding design control. Coordinates activities that address quality issues with customers and regulatory agencies, both domestically and globally. Ensures the Indianapolis Manufacturing Facility (IMF) Quality Policy is understood, implemented, and maintained in the organization. Performs quality planning to drive continuous improvements to the quality system that ensures ongoing effectiveness and efficiency. This position is responsible for assembling individuals required for preparing / completing timely and thorough complaint and CAPA investigations and change controls, and actively participating in the preparation/approval of the investigations and change controls with customers. Position serves as direct customer interface for product technical questions, investigations, CAPA, change controls, and complaints. Position ensures change controls, complaints and investigations are compliant with CFR, FDA and ICH Guidance, global regulatory expectations, and international cGMPs. Position is responsible for oversight of QTS system for management of change controls, complaints, exceptions, issues and CAPAs.

 

Responsibilities include but are not limited to:

Provide Quality Assurance expertise regarding product quality issues to ensure regulations and company standards are met (CFR, FDA and ICH, international cGMPs). Advice provided cross functionally, to Supplier Quality and customers. Provide Quality Assurance leadership to others on appropriate use and implementation of Quality Assurance aspects of design control and commercialization process. Participate as member of various cross functional teams, as assigned to ensure QA principles are applied/ Quality System compliance is achieved. Develop strategy and lead implementation of quality and process control plans on product teams.Continually improve Quality System by investigating, developing, and implementing permanent corrective and preventive actions for process/system failures. Assemble individuals required for preparing / completing timely and thorough investigations, and actively participating in preparing investigations. Collaborate, in a hands-on manner, and provide direction on investigations and technical issues at the Indianapolis facility and at contract manufacturing sites.Investigate, develop, review and/or propose disposition of non-conforming materials; review and approve of product and process change requests, provide investigations, and change controls to customers for QA and regulatory review and approval.Interpret customer strategies into implementation plans for continual improvement in IMF activities; communicate IMF issues to customers; work with customers, as well as directly with vendors to resolve/address quality issues. Interact with stakeholders to drive quality issues to resolution.Analyze customer feedback data, formulate action plans to permanently resolve issues and assembles the appropriate technical resources required to drive the implementation of process and/or system improvements resulting in measurable improvement in product quality and/or customer perception.Supervise and lead site wide effort of designing, conducting, and writing investigations; provide guidance and direction to all departments regarding investigations and appropriate CAPA.Handle/investigate product complaints and provide quality oversight for product specific manufacturing operations.Provide Quality input and oversight to all departments, and customers, on product and process development projects. This includes validation initiatives and providing Quality input / guidance regarding manufacturing operations, process controls, specifications, and validation for new raw materials.As needed, compile data and author memos and reports that are submitted to customers and regulatory agencies in support of product licenses and applications.

 

Who You Are:

 

Minimum Qualifications:

Bachelors Degree in Chemistry, Biology, or other Life Science Discipline and 4+ years of pharmaceutical industry experience in a role responsible for regulatory, complaint handling, and investigation or CAPA activities.

OR

Masters Degree in Chemistry, Biology, or other Life Science Discipline and 2+ years of pharmaceutical industry experience in a role responsible for regulatory, complaint handling, and investigation or CAPA activities.

Preferred Qualifications:

Experience with sterile drug products and biopharmaceuticals.Experience with FDA, and EU GMPs, and ICH Guidance.Experience presenting technical data both internally and externally to customers, inspectors, and auditors.Experience with good documentation practices.Strong planning, organization, influencing skills, strategic perspective, leadership, self-motivated, resilient, team-oriented, and results-oriented.

 

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