Quality Control Admin and IT Services Lead (Guadalajara)

Job Title: Quality Control Admin and IT Services Lead

Introduction to role

As the global domain expert, you will ensure the QC Systems are crafted to meet business requirements including reliability, adaptability, and compliance. You will be responsible for building the system and developing the governing process to ensure standard ways of working are maintained across the QC operation. You will provide technical direction in defining master data requirements and be responsible for master data maintenance activities. You will also deploy key IT systems to the sites, maintain general business usage SOP’s, develop global training documentation, and provide training on the system.

Essential Skills/Experience

• Bachelor of Science degree, preferably in a Science related field.
• A minimum of 7 years’ experience in a cGMP laboratory environment with substantial relevant experience in pharmaceutical Quality Control department.
• Working knowledge of lab systems and their functionality. Prior experience leading implementations of software such as Biovia 1Lab, SmartLab, LIMS, Empower and SAP is strongly preferred.
• Solid understanding of quality systems and health authority requirements such as FDA, EMEA, MHRA, etc.
• Able to work in a highly matrix global organization with a multi-functional team with the ability to influence without authority.

Desirable Skills/Experience

• Excellent IT skills and capable of building and leading databases.
• Solid understanding of Operations processes and how QC interconnects.
• Good level of Lean operational experience.

Location

Primary Location: Guadalajara (hybrid)

English Interpersonal Skills

Strong English interpersonal skills required.

EEO Statement

Positions are open to Mexican Citizens and official residents of Mexico.