Associate Director, Quality Assurance (QA)
Location: Hyderabad, India (Hybrid)
Job ID: 25103098
Updated: December 3, 2025
About the Company
Syneos Health is a leading fully integrated biopharmaceutical solutions organization delivering end-to-end clinical, medical affairs, and commercial services. With a presence in over 110 countries and a global team of more than 29,000 experts, the company is committed to accelerating the journey from laboratory innovation to real-world patient impact.
Position Overview
The Associate Director, QA is responsible for overseeing quality assurance audits, managing inspection readiness, hosting client and regulatory inspections, and providing strategic quality guidance across the organization. This role may also involve managing a team of auditors and supporting continuous improvement initiatives across QA operations.
Key Responsibilities
Audit and Inspection Oversight
Oversee and conduct audits in alignment with QA SOPs and work instructions.
Prepare and review detailed audit reports, ensuring accuracy and compliance.
Lead and support customer audits, including coordination of required documentation and corrective actions.
Develop strategies for inspection readiness across offices, including planning and executing mock inspections.
Host Regulatory Authority Inspections and manage pre-inspection and on-site activities.
Communicate audit findings and support corrective and preventive action plans (CAPA).
Quality Consultancy and Compliance
Provide expert guidance on quality and compliance matters across operational teams.
Recommend improvements to enhance compliance and operational performance.
Participate in the development, revision, and implementation of QA SOPs and work instructions.
Team Leadership and Collaboration
May manage and mentor a team of auditors, ensuring skill development and performance excellence.
Participate in recruitment, training, coaching, and performance evaluations for QA personnel.
Support cross-functional teams, fostering a culture of quality, continuous improvement, and operational efficiency.
Additional Contributions
Represent the organization in industry forums and professional associations.
Coach internal teams on inspection readiness and quality standards.
Participate in organizational projects requiring quality leadership.
Ensure compliance with all internal and regulatory requirements.
Travel up to 25%, as needed.
Qualifications and Experience Required
Education
Bachelor’s degree in a science or healthcare discipline is required.
Advanced qualifications are advantageous.
Experience
Minimum required experience: Significant hands-on experience in GxP Quality Assurance auditing.
Experience range: Typically 8–15+ years of relevant QA experience, with proven expertise in clinical research, pharmaceutical, CRO, or regulated life sciences environments.
Demonstrated experience conducting multiple audit types, including vendor audits, investigator site audits, TMF audits, data management, safety reporting, and laboratory audits.
Prior experience hosting regulatory inspections and managing inspection readiness programs is essential.
Experience in a similar leadership or Associate Director-level role is required.
Technical Skills
Strong understanding of GxP regulatory frameworks.
Proficiency in Microsoft Office and basic SharePoint operations.
Ability to analyze complex quality issues and develop effective solutions.
Skilled in report writing, documentation, and professional communication.
Leadership & Interpersonal Skills
Ability to work independently and proactively manage multiple priorities.
Strong organizational and project management capabilities.
Excellent team-building, negotiation, and feedback-delivery skills.
Cultural awareness and the ability to collaborate with global stakeholders.
Work Environment
Hybrid work model (Hyderabad).
May require international or domestic travel up to 25%.
Must adhere to all internal compliance policies and applicable regulatory standards.
Equal Opportunity Statement
Syneos Health is committed to fostering an inclusive and diverse workplace. Applicants are encouraged to apply even if their experience does not fully match all qualifications listed. Transferable skills and equivalent experience will be considered.
How to Apply
Interested candidates can apply directly through the job link provided on The Pharma Daily or join the Syneos Health Talent Network to remain informed about upcoming opportunities.
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