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Sr. Auditor

7+ years
$101,400 – $152,000
10 Sept. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Auditor

Job ID: 290631
Location: Indianapolis, Indiana, United States
Job Type: Full-time

About Us

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

We are a global leader in Healthcare, Life Science, and Electronics, driven by curiosity and innovation. Together, we push boundaries to enrich lives and shape the future.

Note: This role does not offer sponsorship for work authorization. Applicants must be eligible to work in the US.

Your Role

As a Senior Auditor, you will be responsible for ensuring compliance with cGMP, FDA, EU regulations, and internal quality standards in a pharmaceutical environment. This role involves leading audits, managing quality systems, and overseeing supplier quality to ensure operations align with regulatory and company expectations.

Key Responsibilities
Audit Management

Schedule, prepare, conduct, and report internal and external audits of manufacturing processes, quality systems, and suppliers.

Evaluate compliance with cGMP, FDA, EU, and internal standards.

Prepare detailed audit reports summarizing findings, non-conformances, and recommendations.

Collaborate cross-functionally to implement and monitor Corrective and Preventive Actions (CAPAs).

Track CAPA effectiveness and ensure timely issue resolution.

Quality System Oversight

Participate in mock inspections as needed.

Escalate compliance issues or risks identified during audits or risk assessments.

Ensure alignment with quality standards, manuals, policies, and procedures.

Supplier Quality Management

Conduct supplier audits and assessments for compliance with regulatory and quality standards.

Partner with suppliers to establish corrective actions for deficiencies.

Maintain supplier performance metrics and ensure adherence to quality agreements.

Who You Are
Minimum Qualifications

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent experience.

Minimum 7 years of experience in QA, auditing, or supplier management within pharma, biotech, or cGMP industry.

Auditing experience within regulated biotech/pharma (or equivalent).

Willingness to travel up to 25% domestically (supplier sites, company locations).

Preferred Qualifications

Certified Quality Auditor (CQA) or equivalent certification.

Strong knowledge of cGMP, FDA, EU regulations.

Ability to interpret/apply regulatory guidance and recommend compliance improvements.

Experience in quality system management and supplier quality assurance.

Excellent analytical, communication, and problem-solving skills.

Strong organizational skills, attention to detail, and ability to work independently.

Requires limited supervision.

Compensation & Benefits

Pay Range: $101,400 – $152,000 annually

Actual compensation based on experience, skills, and location.

Eligible for performance-based bonuses.

Benefits include:

Health insurance

Paid time off (PTO)

Retirement contributions

Additional company perks

What We Offer

At MilliporeSigma, we foster inclusion, belonging, and growth for all. With diverse perspectives and backgrounds, we strengthen innovation and drive excellence in science and technology.

Apply Now

Join us and be part of a team dedicated to sparking discovery and elevating humanity.