Principal Professional Quality Risk Manager – Full-Time, On-Site (Pune, MH, India)
Job ID: 25104421-OTHLOC-5580-2DR
Updated: Today
Overview:
Syneos Health®, a global leader in fully integrated biopharmaceutical solutions, is seeking a Principal Professional Quality Risk Manager to provide strategic oversight and consultancy on quality issues across Clinical and Corporate services. This role is ideal for professionals with extensive experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP), and a proven record in quality risk management within biopharmaceutical or healthcare environments.
Key Responsibilities:
Provide consultancy, oversight, and management of quality issues across Clinical and Corporate operations.
Lead root cause analyses and implement corrective and preventive actions to ensure regulatory compliance.
Collaborate with clients, internal teams, and stakeholders to manage quality issues effectively.
Analyze quality trends, potential risks, and mitigation strategies, contributing to continuous improvement initiatives.
Present findings, updates, and recommendations to Quality Management leadership.
Review controlled documents for alignment with organizational standards and technical content.
Lead medium-to-large quality risk management projects with moderate risk and resource requirements.
Support project and customer management activities, ensuring adherence to timelines and commitments.
Essential Requirements:
Bachelor’s degree in science, healthcare, or related field (equivalent education and experience considered).
Significant experience in GCP, GLP, and/or GMP within biopharmaceutical or healthcare environments.
Strong project management and client management skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Excellent attention to detail, organizational skills, and ability to manage multiple tasks simultaneously.
Ability to act independently, proactively, and effectively in a collaborative environment.
Desired Skills & Qualifications:
Experience in process improvement initiatives within Quality Management.
Strong interpersonal, team-oriented, and leadership skills.
Ability to provide guidance to QA auditors, operational staff, and external regulatory parties.
Capability to influence and resolve complex quality challenges.
Additional Details:
Travel: Approximately 15% may be required.
Supervision: This position does not include direct supervision of employees.
Equivalent experience, skills, and education may be considered.
Syneos Health is committed to diversity, inclusion, and reasonable accommodations under the Americans with Disabilities Act.
Why Join Syneos Health:
Work with a global leader supporting 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products.
Be part of a collaborative, diverse, and inclusive culture that values your Total Self.
Engage in meaningful work that accelerates customer success and brings innovative healthcare solutions to patients worldwide.
Opportunities for career growth, training, and development in a dynamic global organization.
Global Impact:
At Syneos Health, work here matters everywhere. Contribute to quality risk management that safeguards clinical and corporate operations, supports regulatory compliance, and drives biopharmaceutical innovation.
Gujarat :
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