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
This position is responsible for assembling all individuals required for preparing / completing timely and thorough investigations, and actively participating in the preparation/approval of investigations. Position ensures investigations are compliant with CFR,FDA and ICH Guidance, global regulatory expectations, and international cGMPs. .
Major Position Activities & Responsibilities:
Supervise and lead site wide effort of designing, conducting, and writing investigations; provide guidance and direction to all departments regarding investigations and appropriate CAPA.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 sitesHandle/investigate product complaints.As needed, compile data and authors reports that are submitted to regulatory agencies in support of product licenses and applicationsPerforms special projects and other duties as assigned.As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.Scope:
Primary responsibility is guiding all STPS investigations, to ensure compliance with regulatory expectations, ensure thoroughness, and ensure effective CAPA are implemented.Functions as a key technical resource in the Quality Operations organizationResponsible for notifying management of any quality issue that require notification of regulatory authorities, e.g. NDA Field Alert reports.Responsible for supporting management during regulatory inspections, e.g. providing details and rationale of STPS investigations.Does not have any direct reports.Who You Are
Minimum Qualifications:
Position requires a Bachelor’s degree in biology, chemistry, pharmacy, or life sciences, and a minimum of 2 years of experience; or at least 4 years of experience in the pharmaceutical industry in a technical or quality role, with prior experience in investigations and CAPA activities.
Preferred Qualifications:
Experience with sterile drug products and biopharmaceuticals preferred.Experience with FDA, and EU GMPs, and ICH GuidanceThe position requires proven ability and skill in analyzing, understanding, and presenting technical dataExperience in technical writing and communicating across organization functions and organizational levels is expected.
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