Associate Vice President - Visual Inspection SME - MSAT

Role Summary

Associate Vice President, Visual Inspection SME - MSAT. Lead the visual inspection program for parenteral pharmaceutical products across a global manufacturing network, providing expert guidance on inspection methodologies, training, system optimization, and harmonization of control strategies to ensure the highest quality and regulatory compliance. Assume accountability for the visual inspection scientists, engineers, and laboratory; require deep technical knowledge, strong leadership, and a commitment to product quality and patient safety.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
• Build the organization for success; recruit strong talent, manage performance, and foster a culture of innovation, inclusion, and respect.
• Evaluate and validate visual inspection processes, including manual and automated methods, to achieve optimal quality outcomes.
• Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes).
• Harmonize visual inspection control strategies and practices across the internal and external manufacturing network.
• Serve as the go-to expert on visual inspection processes, equipment, and quality standards for parenteral product lines.
• Conduct root cause analyses and implement CAPAs for quality-related events.
• Collaborate with cross-functional teams to identify and implement process improvements that enhance efficiency and reduce inspection errors.
• Ensure compliance with FDA and global regulatory standards by keeping inspection processes and documentation up-to-date.
• Participate in internal and external audits, providing expert insights and support for inspection-related findings.
• Develop and maintain internal strategy documents and execution documents (validation reports, etc.) to support the visual inspection programs.
• Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
• Identify opportunities for process automation, working with engineering teams to implement new tools and technologies.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or related field; advanced degree preferred.
• 15+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment.

Skills

• In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products.
• Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections.
• Proven track record of developing training programs and mentoring inspection teams.
• Strong analytical and problem-solving skills, attention to detail, and commitment to quality.
• Experience with automated inspection systems and/or artificial intelligence for quality control is a plus.

Education

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or related field. Advanced degree preferred.

Additional Requirements

• Note: This role may require travel as part of coordinating a global manufacturing network.