Quality Specialist 3 - Compliance and Audits
About this opportunity
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:
Quality Specialist 3 – GMP/GLP Compliance provides independent quality oversight within a GMP/GLP-regulated laboratory environment. This role ensures compliance with regulatory requirements, internal procedures, and client expectations through investigation management, risk-based decision making, audit support, inspection readiness, and continuous improvement. The position partners with operational, technical, and client stakeholders to maintain an effective and inspection-ready Quality Management System (QMS).
Key Responsibilities:
Lead or support client, internal, regulatory audits and inspections.
Lead audit preparation, audit response, and tracking of outstanding compliance initiatives.
Drive inspection readiness activities and track audit commitments, CAPAs, and compliance actions.
Review, approve, and/or lead deviations, investigations, CAPAs, effectiveness checks, change controls, and risk assessments.
Serve as a subject matter expert for root cause analysis (RCA) and quality investigations.
Interpret regulatory requirements and provide compliance guidance to operational teams.
Review and approve SOPs, GMP records, and other quality documentation.
Facilitate risk assessments using tools such as HACCP and FMEA.
Monitor quality metrics and trends, identify systemic issues, and lead continuous improvement initiatives.
Support client meetings, regulatory submissions, supplier qualification activities, and client quality agreements as needed.
Who You Are :
Minimum Qualifications:
Bachelor's degree in a life science discipline.
2+ years' experience in conducting internal audits, client audits, or Client quality agreements in a Quality Assurance role.
2+ years' experience in leading and/or reviewing root cause analysis and CAPA for deviations in a Quality Assurance role
Preferred Qualifications:
Experience in a GxP CRO/CDMO/CTO or multi-client environment.
Experience with inspection readiness programs and regulatory responses.
Experience analyzing compliance metrics and quality trends.
Working knowledge of FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP requirements, and ICH Q9/Q10.
Broad quality systems experience across multiple QA disciplines.
Experience in conducting supplier audits
Demonstrate proven track record of effective communication with internal stakeholders and external clients.
Strong analytical, communication, organizational, and problem-solving skills.
Demonstrated ability to work independently, influence stakeholders, and foster a culture of quality and compliance.
Pay Range for this position: $70,800-106,200 annually
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 .
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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!
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 757 comparable Quality roles across 94 biopharma companies.
Salary context
144 of 757 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 757 comparable roles
+ 42 more countries
Seniority mix
350 of 757 peers have a known seniority level
Therapeutic area mix
1 of 757 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.