Essential Functions:

• Provide guidance and oversight of validation activities across all manufacturing and production processes within the organization.
• Drive validation/qualification strategy and ensure continuous improvement of validation practices across the organization.
• Ensure adherence to regulatory requirements by reviewing validation documentation and maintain compliance with relevant standards.
• Participate in the design of validation/qualification activities.
• Maintain Validation Master Plans, Project Validation/Qualification plans, risk assessments, protocols, and reports to GMP standards.
• Identify areas for improvement within validation activities, propose changes to optimize procedures and enhance efficiency.
• Identify potential risk associated with processes and product and collaborate with subject matter experts to implement mitigation strategies to minimize quality issues.
• Work closely with manufacturing, regulatory, and quality operations to address quality concerns.
• Stay updates on industry trends and regulatory changes to ensure compliance in validation processes.
• Participate in root cause analysis for validation deviations, developing corrective and preventative actions.
• Establish and revise quality assurance procedures and policies.
• Promote a quality mindset and quality excellence approach to all activities.

Requirements:

• BS or BA with 10+ years relevant industry experience.
• Demonstrate in-depth knowledge of GMPs, FDA and EU requirements and ICH guidelines.
• Must have a strong understanding of quality assurance principles and validation methodologies.
• Possess technical knowledge of manufacturing processes and equipment.
• Excellent analytical and problem-solving skills to interpret data and identify root causes.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Knowledge and experience in Risk Management principles.
• Vaccine experience desired.
• Strong Management and process improvement skills.
• Demonstrate a high level of independent quality judgment.
• Demonstrate excellent verbal, written, and interpersonal communication skills.
• Demonstrate experience leading and contributing through influence and working in cross functional teams.
• Strong sense of ownership in areas of responsibility.
• Ability to travel up to 30% domestically and internationally.