Senior Validation & Quality Assurance Leader

Grifols, S.A; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Grifols, a global healthcare company, seeks a Manager, Validation to lead cGMP compliance, QA/QA documentation, and validation activities across processes, information systems and equipment.

Based in RTP, NC, the role follows a hybrid schedule (2 days in the office, 3 days remote) and requires a Bachelor's degree in a scientific field and about 8 years of quality and validation experience in cGMP or IT environments.

Qualifications

• Proficiency with cGMP operating procedures and validation standards.
• Experience writing validation/test documentation and summaries.
• Strong analytical, communication and problem-solving skills.

Responsibilities

• Manage resources and prioritize work to meet timelines.
• Develop cGMP SOPs related to validation/qualification.
• Ensure SOP compliance and support investigations and corrective actions.
• Support Change Control and Supplier Quality functions.
• Coordinate validation testing with Donor Center and Field QA/Operations.
• Develop and maintain validation templates and test cases.
• Execute test cases and document results.
• Communicate findings across QA and operations teams.
• Monitor validation milestones and evaluate effectiveness of protocols.
• Identify actions to update processes, systems, and equipment.

Skills

cGMP knowledge

Validation testing

Documentation

Quality systems

Education

Bachelor's degree in a scientific field

Job description

Grifols, a global healthcare company, seeks a Manager, Validation to lead cGMP compliance, QA/QA documentation, and validation activities across processes, information systems and equipment.

Based in RTP, NC, the role follows a hybrid schedule (2 days in the office, 3 days remote) and requires a Bachelor's degree in a scientific field and about 8 years of quality and validation experience in cGMP or IT environments.