Manager, QA Validation Oversight

About the role

This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.

Responsibilities

• Ensure alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.
• Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.
• Present/defend validation strategies, documentation, and processes to FDA and other regulatory agencies.
• Review and approve process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
• Oversee all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
• Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.

Requirements

Hands-on validation experience in a GMP-regulated environment. Deep understanding and expertise in Process Validation. Continuous improvement mindset. Experienced leader who inspires and guides a multi-tiered team.

Qualifications

• Associate Manager: 6+ years
• Manager: 7+ years

Skills

Hands-on validation experience in a GMP-regulated environment. Deep understanding and expertise in Process Validation. Continuous improvement mindset. Experienced leader who inspires and guides a multi-tiered team.

Benefits

See details in the job description.

Pay

$90,800.00 - $173,400.00 annually

Schedule

See details in the job description.