Description

You will oversee manufacturing operations and validation processes to ensure all systems, equipment, and facilities comply with regulatory standards and internal quality requirements.

Responsibilities

• Lead the qualification of new equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Manage the validation of manufacturing processes, software, and IT systems, including MES and ERP platforms.
• Develop and execute comprehensive validation plans, protocols, and reports in alignment with regulatory guidelines.
• Address deviations and non-conformances by initiating and resolving Corrective and Preventive Actions (CAPA).
• Direct manufacturing and validation teams, providing technical guidance and mentorship to onshore and offshore staff.

Required Skills

• 5-10 years of experience in Quality or relevant process roles within a regulated environment.
• 3-8 years of experience in people leadership.
• Proven experience in manufacturing operations and validation within the medical device, pharmaceutical, or food manufacturing industries.
• Deep understanding of GMP, FDA 21 CFR Part 820, and ISO 13485 standards.
• Expertise in process validation (PV) and re-validation methodologies.
• Ability to manage and lead both onshore and offshore teams.
• Strong end-to-end process understanding and knowledge of Quality Management Systems (QMS).
• Experience interacting with cross-functional teams, senior management, and external auditors.
• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related field.

Key Skills

Education

Any Gradute