18 set - Ivrea
Novartis
Salary Range:€61,800.00 - €114,800.00
La preghiamo di leggere attentamente la panoramica e i requisiti per questa occasione di lavoro riportati di seguito.
Job Description SummaryWe are seeking an experienced Associate Director, Analytical Operations to lead GMP Analytical Operations within the TRD RLT Pilot Plant in Ivrea. This leadership role is responsible for analytical operations, quality compliance, laboratory performance, continuous improvement, and team development.
Location: Ivrea, Italy
Job DescriptionKey Responsibilities
- Lead the GMP Analytical Operations team and drive execution of strategic objectives and KPIs.
- Provide end-to-end oversight from sample receipt through analytical result release.
- Ensure compliance with GMP requirements, data integrity standards, and quality systems.
- Lead investigations related to deviations, OOE, OOT, and OOS events and implement CAPAs.
- Develop laboratory strategies, resource plans, SOPs, and operational improvements.
- Manage laboratory budgets in partnership with site leadership.
- Support internal audits,
regulatory inspections, and quality reviews.
- Build a high-performing team through coaching, talent development, and recruitment.
- Promote a strong safety culture and compliance with HSE requirements.
Additional Responsibilities
- Oversight of maintenance and qualification activities for pilot plant equipment and facilities.
- Review and approval of analytical batch documentation and validation-related records.
- Approval of quality documentation including SOPs, CAPAs, deviations, and quality events.
Requirements
- Degree in Pharmacy, Biology, Chemistry, Engineering, or related scientific discipline.
- Minimum 7 years of Quality Control and/or Analytical Science experience within the pharmaceutical industry.
- Strong knowledge of GMP regulations, analytical technologies, laboratory equipment qualification, and data integrity principles.
- Experience with systems such as LIMS, Chromeleon, QEM, and Micro
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