Associate Director Analytical Operations

Novartis; Ivrea; Ibrido; EUR 62.000 - 115.000; Tempo pieno

Vantaggi offerti da questo lavoro

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

14 weeks parental leave

Descrizione del lavoro

Novartis is seeking an experienced Associate Director, Analytical Operations to lead GMP Analytical Operations within the TRD RLT Pilot Plant in Ivrea, Italy. This leadership role covers analytical operations, quality compliance, laboratory performance, continuous improvement, and team development.

Location: Ivrea, Italy. The role requires strong leadership, regulatory knowledge, and collaboration with site leadership to manage budgets, CAPAs, and audits.

Competenze

• 7+ years of Quality Control/Analytical Science experience in the pharmaceutical industry.
• Strong knowledge of GMP, data integrity, and quality systems.
• Experience with LIMS, Chromeleon, QEM, and MS Office.
• Proven leadership and team development skills.

Mansioni

• Lead GMP Analytical Operations team and KPIs.
• Oversee end-to-end sample receipt to result release.
• Ensure GMP compliance and data integrity standards.
• Lead investigations of deviations, OOE, OOT, and OOS events and implement CAPAs.
• Develop laboratory strategies, resource plans, SOPs, and improvements.
• Manage laboratory budgets in partnership with site leadership.
• Support internal audits, regulatory inspections, and quality reviews.
• Build a high-performing team through coaching and recruitment.
• Promote a strong safety culture and compliance with HSE requirements.

Conoscenze

Leadership

Communication

Organizational skills

Italian (written and spoken)

English (written and spoken)

Formazione

Degree in Pharmacy, Biology, Chemistry, Engineering, or related scientific discipline

Strumenti

LIMS

Chromeleon

QEM

Microsoft Office

Descrizione del lavoro

Salary Range:

€61,800.00 - €114,800.00

Job Description Summary

We 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 Description

Key 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 Microsoft Office.
• Excellent leadership, communication, and organizational skills.
• Fluent written and spoken Italian and English.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: € 61,800 to € 114,800

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.

In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Skills Desired

• Budget Management
• Data Science
• Process Simulation
• Waterfall Model