Quality Validation Manager

About the role

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.

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.

Benefits

• Medical, dental, vision, telemedicine
• Term life, whole life, accident insurance, critical illness, legal plan, short‑term disability
• Retirement savings plan
• Service bonus and holiday pay plans (up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave (per applicable state or local plan)

Pay

$135,000 per year

Schedule

Monday‑Friday, 1st shift