Validation Manager Jobs

Job Title: Validation Manager

Job Summary:

Our client seeks a Validation Manager, one who will play a pivotal role in overseeing and ensuring the successful implementation of validation programs across our diverse portfolio of products and processes. This position requires a strong understanding of industry regulations, validation principles, and quality systems, as well as excellent leadership and communication skills.

Our client seeks highly motivated, performance-driven individuals to join our expanding team.

Responsibilities:

• Ensure team training and awareness of validation and design control regulations.
• Collaborate with Technical, Engineering, Quality, and R&D functions to implement changes effectively.
• Actively manage project validation and design quality engineering teams for successful execution.
• Develop Validation Strategy for multi-million-dollar capital investments, gaining cross-functional leadership alignment.
• Manage Validation program for Strategic Capacity Expansions, ensuring success of large-scale capital projects.
• Develop validation strategy for significant 100+MM and 1.2B Capital Investments.
• Identify root causes and solutions for unexpected outcomes to maintain validation integrity.
• Highlight quality/compliance issues and facilitate timely decisions for new/changed product supply.
• Provide guidance on validation and design control strategies, including product, process, and equipment changes.
• Ensure quality and compliant product development and delivery to meet business and customer needs.
• Oversee approval of change processes and design control documentation to meet requirements.
• Act as Subject Matter Expert (SME) for validation, design control processes, and statistical methods.
• Develop metrics to monitor progress and compliance of change, validation, and design control processes.
• Assure team compliance with quality and regulatory standards, divisional, and local requirements.
• Navigate challenges between project execution and policy requirements for compliant outcomes.

Qualifications:

• 3 years experience in Quality Management
• Bachelor's Degree or equivalent in a scientific/engineering discipline
• Minimum of 8 years experience in manufacturing with a Life Sciences company or in a regulated industry
• Strong working knowledge of applicable regulations (FDA CFR Part 820, Part 11 regulations, and ISO 13485 standards).

If you are interested in this opportunity, please apply!