Required Qualifications** + 10+ years QC Microbiology experience, including supervisory or managerial responsibility + Deep experience supporting aseptic manufacturing of sterile drug products + Expertise in EM, CCS, APS, water systems, sterility assurance, and microbiology lab operations + Strong working knowledge of global regulations (FDA 21 CFR 210/211, EMA Annex 1, ICH, USP) + Proven ability to lead investigations, CAPAs, risk assessments, and data trending + Excellent communication skills with the ability to influence and educate teams + Ability to travel up to 70% domestically and internationally **Preferred Qualifications** + Prior consulting experience + Experience with facility startup, remediation, or major operational readiness efforts + ASQ CQA or similar certification + Experience preparing for and supporting FDA/EMA regulatory inspections + Strong experience authoring technical or regulatory documentation **What We Offer** + **A meaningful mission** -improving patient safety across global manufacturing sites + **High-impact work** with major biopharma and sterile drug product companies + **A culture of support, collaboration, and empathy** -true to our "With Heart" value + **Consulting development and mentorship** , including structured support for those new to consulting + **Flexibility** -remote work when not on client site, plus variety in daily responsibilities **Ready to Make a Global Impact?** Our consultants don't just guide clients through compliance challenges; they become trusted partners helping sterile drug manufacturers deliver safe, effective therapies to people worldwide.