Site Remediation Lead - Saluggia, Italia - Novartis
Descrizione
Reporting to the Site Quality Head, the Site Remediation Lead is responsible for executing remediation project plans at the site, ensuring successful completion of remediation commitments and successful inspection outcomes.
This role is also responsible for coordinating the site's routine remediation tactical meetings, reporting status and risk, and driving resource management, fulfilling Quality and Tech Ops remediation commitments and initiatives.
This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level.
Work location:
Saluggia (TO)
Your responsibilities include, but are not limited to:
- Right-hand person for the Site Quality Head with respect to the site's Remediation Plan
- Execute, monitor, and control Site Remediation Project Plan for overall strategic implementation of deliverables within the site's commitments to Health Authorities.
- Manage a sitebased team of resources responsible for the execution of remediation tasks relevant to the site's remediation objectives.
- Work in close collaboration with the site's Tech Ops and Quality associates, as well as RLT Global Remediation Task Force Lead, RLT Global Remediation Project Manager, and global technical functions (i.e. Global Engineering, Global QC, Global Sterility Assurance) to harmonize remediation strategy and outcomes across the RLT platform.
- Responsible for routine reporting of the site based Remediation Plan status to appropriate stakeholders and delivering relevant content to Global Remediation Task Force and/or Remediation Steering Committee meetings, on behalf of the Site Quality Head.
- Drive the site's Inspection Readiness program for regulatory inspections, internal audits and providing handson support at sites in preparing for inspections / audits
- Define and plan agendas, deliver content and/or lead preparation for key sitebased remediation management engagements and governance meetings including, but not limited to, Site Remediation Tactical Meetings, project governance meetings, and other core Strategy team meetings.
- Leverage project tools and templates to ensure streamlined project management across the network and adherence to strategic remediation communications plan.
- Identify and mitigate projects risks, including timely escalation to Local and Corporate management.
Commitment to Diversity & Inclusion:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum requirements
What you'll bring to the role:
- Graduate in Chemistry, Pharmacy, Microbiology or another related science and/or recognized formal project management qualification (PMP/APMP/Prince2/P30 or equivalent) desirable.
- Minimum of 3 years of experience in qualitybased roles including experience in GMP and/or laboratory operations required
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections is preferred.
- Good understanding of local/National Health Authorities regulations and Novartis standards
- Demonstrated leadership, negotiation, teamworking and conflict resolution skills both internal and external (cross network relationships)
- Strong analytical skills, problem solving ability and presentation required
- Languages: English fluently, verbally and in writing. Knowledge of Italian is highly favourable.
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day.
At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer.
How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying Imagine what you could do here at NovartisImagine what you could do at Novartis
Join our Novartis Network:
Division
Oncology
Business Unit
ADVANCED ACCELERATOR APPLICATIONS
Country
Italy
Work Location
Saluggia
Company/Legal Entity
AAA Italy Srl.
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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