Data Governance Lead

hace 6 días


Guadalajara, Jalisco, México Pharmatech Associates A tiempo completo

We are seeking a Data Governance Lead to oversee the development and implementation of a comprehensive data governance program for our client in the pharmaceutical industry. This program will be responsible for ensuring the accuracy, completeness, and integrity of data throughout the product lifecycle.

Key Responsibilities:
- Develop and implement a data governance framework that aligns with industry regulations and company policies.
- Lead the escalation of data integrity issues to senior management levels as needed.
- Provide oversight for the governance, management, and coordination of data-related activities, including training and compliance activities throughout the product lifecycle.
- Identify areas for improvement in data integrity risk detection and mitigation and implement corrective actions.
- Ensure compliance with all regulatory requirements related to data integrity, company policies, and procedures.

Requirements:
- Bachelor's Degree plus 10 years of experience in the pharmaceutical industry supporting manufacturing and quality operations.
- Experience and in-depth knowledge of GxP computerized systems validation and 21 CFR Part 11, GAMP 5, and CSV requirements.
- Experience in FDA-regulated environments, including US 21 CFR Part 210 & 211 Current Good Manufacturing Practice and direct experience dealing with FDA.
- Cross-functional experience in the pharmaceutical industry, including manufacturing, engineering, quality assurance, quality control, etc.
- In-depth knowledge of data integrity requirements and validation of computerized GxP systems.



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