Quality Validation Manager

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Kelly Science is seeking a Quality Validation Manager to lead the Validation Team in Raleigh, NC. You will drive cGMP compliance and oversee qualification, validation, and revalidation for site equipment, systems, processes, and facilities, coordinating with cross-functional teams.

You will manage audits, risk assessments, change proposals, and GMP documentation, mentoring staff and external contractors to achieve operational excellence in a regulated pharmaceutical environment.

Qualifications

• Bachelor's degree in a life sciences related field.
• Minimum of 10 years’ pharmaceutical validation experience and 8 years’ supervisory experience.
• Deep knowledge of validation life cycle and IQ/OQ/PQ protocols, steam sterilization, equipment qualification, cleaning, and process validation.
• Strong leadership, coaching, mentoring, and departmental management skills.
• Ability to prioritize, multitask, communicate, and stay organized in a fast-paced, regulated manufacturing environment.

Responsibilities

• Oversee daily operations and provide leadership for the Validation department, managing both internal staff and external contractors.
• Develop, maintain, and improve validation systems, policies, and procedures to ensure compliance with cGMP FDA/EMEA regulations.
• Manage and review validation activities, including qualifications, revalidations, risk assessments, and documentation for equipment, processes, and facilities.
• Support cross-functional teams in site projects, regulatory initiatives, and process improvements; participate in audits and inspections.
• Lead and manage large-scale validation projects, coordinate with stakeholders, supervise contractors, and drive operational excellence initiatives.

Skills

Leadership

Regulatory compliance

Communication

Risk assessment

Project management

Education

Bachelor's degree in life sciences

Job description

Kelly Science is seeking a Quality Validation Manager for a growing team located in Raleigh, NC.

Shift

Monday- Friday 1st Shift

Employment Type

Full Time; Direct Hire

Summary

As Quality Validation Manager, you will lead the Validation Team in providing excellent customer service and ensuring compliance with cGMP and FDA/EMEA regulations. Serving as the validation expert, you will oversee qualification, validation, and revalidation for site equipment, systems, processes, and facilities, and drive improvement initiatives. You’ll collaborate with cross-functional teams, conduct risk assessments, review change proposals, author and approve protocols and reports, address deviations, and maintain GMP documentation.

Job Responsibilities

• Oversee daily operations and provide leadership for the Validation department, managing both internal staff and external contractors.
• Develop, maintain, and improve validation systems, policies, and procedures to ensure compliance with cGMP FDA/EMEA regulations.
• Manage and review validation activities, including qualifications, revalidations, risk assessments, and documentation for equipment, processes, and facilities.
• Support cross-functional teams in site projects, regulatory initiatives, and process improvements; participate in audits and inspections.
• Lead and manage large-scale validation projects, coordinate with stakeholders, supervise contractors, and drive operational excellence initiatives.

Qualifications

• Bachelor's degree in a life sciences related field
• Minimum of 10 years’ pharmaceutical validation experience and 8 years’ of supervisory experience
• Deep knowledge of validation life cycle and protocols (IQ/OQ/PQ), steam sterilization, equipment qualification, cleaning, and process validation.
• Strong leadership, coaching, mentoring, and departmental management skills, including performance reviews and establishing group objectives.
• Ability to prioritize, multitask, communicate, and stay organized in a fast-paced, regulated manufacturing environment.
• Proficient in quality issue identification, corrective/preventative actions, regulatory compliance (cGMP, cGLP, cGXP, FDA, ICH, EMEA, 21 CFR 11), and conducting audits.
• Experience with process improvements, document approvals, troubleshooting, problem-solving, risk assessment, and supporting department goals.