The Software Quality Validation Manager will report to the Global Director of Quality. This is a new role in the CCT organization and will require hands on testing as well as overall organizational development. This role will oversee the quality and compliance of all CCT’s Digital Solutions by developing and implementing validation strategies, managing validation projects, and ensuring adherence to regulatory requirements and company standards. They lead teams, mentor staff, and collaborate with various departments to guarantee the reliability and effectiveness of software applications.
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%)
Preferred Qualifications:
- Working knowledge of cGMP and GDP preferred
- Six Sigma Green Belt or Lean Certification