Sr Manager, QA Validation

at  Thermo Fisher Scientific

JOB SUMMARY:

The Senior Manager of QA Validation will provide oversight and manage the validation activities across all manufacturing and production processes within the organization. This role ensures that all products, equipment, systems, and facilities meet quality standards and align with regulatory requirements. The Senior Manager will lead a team professionals, drive validation strategy, and ensure continuous improvement of validation practices across the organization.

QUALIFICATIONS:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• Minimum of 8-10 years of experience in Quality, Validation or equivalent within the pharmaceutical, biotech, medical device, or related regulated industries.
• Proven leadership experience developing teams and projects.
• Strong understanding of validation principles, including equipment, process, and computer system validation.
• Detailed knowledge of cGMP, FDA, EMA, ISO, and other regulatory requirements related to validation.
• Excellent project management skills with the ability to manage multiple projects simultaneously.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

PREFERRED SKILLS:

• Experience with statistical methods and risk-based validation approaches.
• Familiarity with software validation and 21 CFR Part 11 compliance.
• Experience in lean manufacturing and continuous improvement methodologies (e.g., Six Sigma, Lean).

Leadership & Strategy:

• Lead the QA validation team, providing guidance, mentoring, and performance management.
• Develop and implement validation strategies and policies in alignment with company goals and regulatory standards (FDA, EMA, ISO, etc.).
• Collaborate with cross-functional teams, including manufacturing, engineering, R&D, automation, and regulatory affairs, to ensure validation plans meet business objectives.

Validation Process Oversight:

• Oversee the development, execution, and review of validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Ensure detailed and compliant validation documentation, including risk assessments, protocols, and final reports.
• Maintain validation master plans, timelines, and metrics to supervise progress and compliance.

Regulatory Compliance:

• Ensure all validation activities and procedures are in compliance with applicable regulatory requirements and internal quality standards (cGMP, GxP, etc.).
• Prepare for and represent the QA validation function during regulatory inspections and audits.
• Stay updated on industry trends and regulatory changes to ensure compliance and continuous improvement in validation processes.

Continuous Improvement:

• Identify areas for process improvements in validation practices, implementing changes to improve efficiency, compliance, and effectiveness.
• Participate in root cause analysis for validation deviations and non-conformances, developing corrective and preventive actions (CAPAs).

Risk Management:

• Conduct risk assessments related to validation activities and ensure proper mitigation strategies are in place.
• Work with the quality and engineering teams to assess the impact of process and equipment changes and determine re-validation requirements.