HA
HarveyIT Operations Manager
IT Operations Manager leading a global IT support function for Harvey. Managing a team across multiple locations ensuring a reliable technology experience for all employees.
About the role
- Lead and execute method qualification and validation activities in alignment with ICH guidelines and GMP standards
- Support and oversight of routine QC testing of plasmid, drug substance (DS) and drug product (DP), including release and stability studies
- Collaborate with CMOs and CROs to ensure timely and compliant execution of analytical activities
- Author and review technical documentation including validation plans, protocols, reports, SOPs, and CoAs
- Manage validation timelines and proactively provide solutions to method challenges
- Participate and lead investigations (OOT/OOS), CAPAs, and continuous improvement initiatives
- Review and trend analytical data routinely for specification evaluation
- Ensure compliance with internal quality systems and regulatory expectations
- Contribute to cross-functional CMC discussions and provide technical input on overall analytical strategy
Requirements
- Minimum BS in Sciences with at least +5 years’ experience OR MS and 2+ years
- Strong understanding of ICH Q2(R2) and GMP principles including compendial methods and data integrity
- Proficiency in HPLC, UV-Vis, Empower, bioassays, qPCR and other analytical platforms and compendial methods
- Experience managing external partners (CMOs/CROs)
- Technical writing skills: drafting and reviewing validation plans, protocols, reports, SOPs, and CoAs
- Experience with OOS/OOT investigations, CAPAs, and root cause analysis
- Project management skills to manage validation timelines and deliverables
- Familiarity with FDA and EMA expectations for QC and validation
- Statistical analysis experience using JMP, Minitab or equivalent
- Minimal travel to CMOs required
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
- Hybrid role (minimum 3 days onsite)
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