Description

JOB SUMMARY

The QA Validation Manager is responsible for overseeing and executing the validation of computerized systems to ensure compliance with GxP regulations, data integrity principles, and regulatory requirements (FDA, EMA, and global standards). This role focuses on quality assurance (QA) by ensuring that all systems, processes, and procedures meet quality standards and support business operations in a compliant and controlled manner.

This position manages the validation lifecycle for software, hardware, and infrastructure systems, ensuring that they are in compliance with quality and regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. The QA CSV Manager will also play a crucial role in managing risk, ensuring audit readiness, and driving continuous improvement initiatives within the quality management framework.

JOB RESPONSIBILITIES

Computer System Validation (CSV) from a QA Perspective:

Develop and maintain validation strategies and quality plans to ensure compliance with regulatory requirements.Ensure the accurate and timely completion of system validation deliverables, including the Validation Master Plan (VMP), User Requirements Specifications (URS), protocols (IQ/OQ/PQ), test scripts, and validation reports.Oversee and approve the validation documentation in alignment with QA processes, ensuring that all validation efforts meet the necessary quality standards and compliance requirements.Manage and maintain validated states for computerized systems, ensuring ongoing compliance through periodic reviews, change control processes, and system revalidation as necessary.

Compliance & Risk Management:

Lead risk management activities for computerized systems, performing risk assessments to identify critical areas and develop risk mitigation strategies.Ensure validation efforts follow a risk-based approach (aligned with GAMP 5) to prioritize the validation of high-risk systems and ensure their integrity.Monitor and enforce adherence to regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and other global GxP regulations.

Cross-Functional QA Collaboration:

Partner with IT, Project Management, Operations, and Quality Control teams to ensure the successful planning and execution of validation activities across the business.Work with software vendors and service providers to ensure they adhere to internal QA and validation processes and comply with regulatory standards.

Audit Readiness & Quality Compliance:

Ensure all validated systems are audit-ready at all times by maintaining complete, accurate, and compliant validation documentation.Act as the QA subject matter expert (SME) for computerized systems during regulatory inspections, client audits, and internal QA audits, addressing any findings or observations related to CSV.Regularly review and assess validated systems to ensure they continue to meet compliance requirements through routine audits and system health checks.

Data Integrity and System Controls:

Ensure all computerized systems are designed and validated to comply with data integrity principles, maintaining traceability, accuracy, and security of data throughout its lifecycle.Implement robust controls for data security, backup, and disaster recovery, ensuring the protection of regulated data.

Continuous Improvement in QA Processes:

Drive continuous improvement initiatives to enhance the quality and compliance of validation activities, leveraging industry best practices and regulatory updates.Periodically review and update Standard Operating Procedures (SOPs) to reflect evolving regulatory expectations and emerging technologies.

Training & QA Leadership:

Provide training and guidance to cross-functional teams on CSV principles, data integrity, and regulatory compliance as part of the QA framework.Mentor junior QA team members and support their development in system validation and regulatory compliance.

QUALIFICATION REQUIREMENTS

Education / Experience:

Bachelor’s degree in a relevant field, such as Computer Science, Engineering, Life Sciences, or Quality Assurance.8+ years of experience in computer system validation within a regulated industry (pharmaceutical, biotechnology, or medical devices).Experience in a quality assurance role, with a strong focus on computer system validation, regulatory compliance, and risk management.Proven experience leading validation efforts from a QA perspective, with the ability to enforce quality standards and foster cross-functional collaboration.Strong leadership and decision-making abilities to manage validation projects and ensure compliance across the business.

Regulatory and Compliance Expertise:

Strong knowledge of GxP regulations (FDA, EMA), including 21 CFR Part 11, EU Annex 11, 
 and other regulatory requirements for computerized systems in life sciences.Expertise in implementing and maintaining compliance with data integrity principles in validated systems.Understanding of global validation standards, such as GAMP 5

Risk-Based Validation Approach:

Experience applying risk-based methodologies to prioritize validation efforts and mitigate 
 compliance risks.Ability to assess system risks and ensure validation processes are both efficient and aligned 
 with regulatory expectations.

Documentation & Change Control:

Strong attention to detail in reviewing and approving validation documentation to ensure completeness, accuracy, and compliance with internal and external standards.Experience managing change control processes and ensuring that any changes to validated systems are properly controlled and compliant with regulatory requirements.

Project Management Skills:

Ability to manage multiple validation projects, balancing priorities, timelines, and resources while ensuring high standards of quality and compliance.Strong organizational skills and the ability to coordinate between various departments, including IT, QA, and regulatory affairs.

Communication & Training:

Excellent communication skills, with the ability to explain technical validation concepts to non-technical audiences, including regulatory inspectors, auditors, and internal teams.Experience developing and delivering training programs on CSV and compliance topics to ensure organizational awareness and readiness.

The annual base salary for this position ranges from $121,901.00 - $148,800.00. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? We partner with industry experts to solve and execute against today’s toughest commercialization challenges facing the world’s leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world. 

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Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.