Overview
The role is situated in the Global Quality Systems team, with a major influence on one of the company's most critical projects. The position involves developing, then rolling out and implementing a new Quality Management System. This will provide an opportunity to lead an experienced team and grow it in the long-run.
Responsibilities
- Lead and manage new LabWare LIMS implementations.
- Manage LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS).
- Leadership of a global team that cover CSV and Quality digital systems.
- Define and drive
- Full oversight of computerized system validation activities.
- Maintaining compliance with relevant regulatory standards, including FDA.
- Act as SME during regulatory Audits and local inspections.
- Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment.
- Proactively identify risks and drive corrective and preventive actions (CAPAs).
Qualifications
Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.Excellent English communication skills, and Spanish proficiency is a bonus.Experience working with LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS).Minimum of 6 years' experience in pharmaceutical or biotechnology industry.Strong understanding of EU and FDA regulations for pharmaceutical R&D, manufacturing, and distribution.15% travel requirement.Benefits
Competitive remuneration.Clear growth and development plan.Work within a global team.Make an impact on lives globally.#J-18808-Ljbffr