Location: Remote
Job Summary
This position supports the external vendor audit program and acts as a Subject Matter Expert (SME) for Vendor Qualification and Approval at the Indianapolis site. The candidate will also oversee vendor lifecycle management, with experience in conducting internal and vendor audits across early to late phases and commercial CGMP pharmaceutical manufacturing and testing. A working knowledge of FDA and EU regulations is required. Experience with Electronic Quality Management Systems (EQMS) such as SAP, TrackWise, MasterControl, and Veeva is beneficial. Knowledge in microbiology and radiopharmaceuticals is a plus.
Job Responsibilities:
- Author and maintain external audit schedule
- Schedule and coordinate external vendor audits
- Review, communicate and track audit findings
- Create, review, approve, and track corrective actions related to external audits.
- Support the review, discussion and approval of Quality Agreements for external vendors
- Participate in vendor reviews, provide input for the topics that relate to vendor performance and audits outcome.
- Support site activities that relate to the vendor change notification program and vendor complaint management program.
- Help establish and maintain the Vendor Management program
- 50% of travel or as required
- Direct communication to Vendor, schedule and conduct on site, virtual or paper audit/assessment
- Report writing and Vendor performance metrics
- Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.
- Supporting an early phase to commercial facility
Education and Experience:
- 4-year science degree, advanced degree a plus
- 5 years of GMP Pharmaceutical manufacturing or equivalent, late phase and commercial preferred
- ASQ Auditing certificate or equivalent a plus
Skills and Qualifications:
- FDA CFR and EU Annex regulations
- Analytical problem solving
- Pharmaceutical manufacturing with parenteral experience
- Writing procedures, reports, metrics and dashboard
The starting compensation for this job is a range from $79,841-108,020, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
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