Software Quality Validation Manager

Responsibilities:

• Maintain a technical understanding of all integrated systems supporting the digital platform and how they impact the business go-to market strategy.
• Design and implement comprehensive validation strategies aligned with business objectives and regulatory requirements. This includes defining validation scope, objectives, and methodologies.
• Oversee the planning, execution, and completion of validation projects, ensuring they are completed on time and within budget. This includes hands-on testing, managing resources (both internal and offshore supplier partners), timelines, and budgets.
• Ensure that all validation activities comply with relevant regulatory guidelines, such as those from the FDA and EU, as well as industry standards and company policies.
• Oversee the development, review, and approval of validation documentation, including plans, protocols, reports, and standard operating procedures (SOPs).
• Work with manufacturing sites to ensure that protocols are in place to support operators interact with the software applications.
• Monitor and analyze validation data, identify trends, and implement process improvements to enhance the efficiency and effectiveness of validation activities.
• Provide training and guidance to team members and other departments on validation of the best practices and regulatory requirements.

Requirements:

• Bachelor’s Degree with 5 – 10 years of experience; ideally in a related scientific discipline.
• Proven experience in leading and managing validation teams, with strong project management skills.
• Strong understanding of validation principles and practices, including software validation, process validation, and computer system validation.
• Extensive knowledge of regulatory requirements and guidelines, such as those from the FDA and EU.
• Experience with various testing tools and technologies, including test management systems and automation framework.
• Ability to effectively communicate technical information to both technical and non-technical audiences.
• Ability to meticulously document validation activities and ensure accuracy.
• Ability to analyze test data, identify issues, and develop solutions.
• Strong organizational and follow-up skills,
• Critical thinker with analytical proven problem-solving skills.
• Proven experience working with a global team.
• Effectively manage multiple and changing priorities.
• Ability to work in a very fast-paced environment.
• Experience working in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices.
• Project Management (conducting status meetings, project reporting, etc) is a plus.
• Work related travel required – domestic and international (up to 25%)

• Working knowledge of cGMP and GDP preferred
• Six Sigma Green Belt or Lean Certification