Manager, QA (Process Validation Oversight)

Role Summary

Manager, QA (Process Validation Oversight) to lead a team dedicated to ensuring the integrity of process validation processes, supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and aiding regulatory inspections and compliance.

Responsibilities

• Ensuring 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.
• Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
• Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
• Overseeing 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.

Qualifications

• Required: Hands-on validation experience in a GMP-regulated environment.
• Required: Deep understanding and expertise in Process Validation.
• Preferred: Ability to build strong, collaborative relationships across global internal teams.
• Preferred: Continuous improvement mindset.
• Preferred: Experience as a leader who inspires and guides a multi-tiered team.
• Education/Experience: Bachelor’s degree in Engineering, Chemistry, or Life Sciences with minimum years of experience:
  • Associate Manager: 6+ years
  • Manager: 7+ years
• May substitute relevant experience in lieu of education requirement. Level determined by qualifications relevant to the role.

Skills

• Process Validation strategy development and execution
• Regulatory inspection readiness and interaction
• Documentation review and approval (validation protocols, SOPs, reports)
• Change control and failure investigation management
• Leadership and people development

Education

• Bachelor’s degree in Engineering, Chemistry, or Life Sciences (or equivalent experience in lieu of education requirement)