Principal Professional – Quality Risk Manager
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25104421-OTHLOC-5580-2DR
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers end-to-end solutions that shorten the distance from lab to life. With over 29,000 employees across 110 countries, the organization supports innovative therapies that address complex global healthcare challenges.
Position Overview
The Principal Professional – Quality Risk Manager provides strategic leadership, oversight, and consultancy for Quality Issue (QI) management across Clinical and Corporate operations. This role is responsible for identifying, assessing, and mitigating quality risks, leading root cause analyses, and ensuring compliance with global regulatory standards, including GCP, GLP, and GMP.
Key Responsibilities
Quality Risk Management and Oversight
Provide expert support and consultancy on quality issues arising across clinical and corporate services
Lead and facilitate root cause analyses (RCA) and oversee the implementation of corrective and preventive actions (CAPA) to meet regulatory and internal quality requirements
Investigate quality trends, emerging risks, and mitigation strategies in collaboration with QI Management leadership
Participate in client-facing meetings to address quality issues and ensure alignment with project and regulatory expectations
Escalate critical quality risks to Corporate Quality leadership as required
Process Improvement and Compliance
Contribute to or lead quality process improvement initiatives to enhance QI management effectiveness
Ensure adherence to Syneos Health timelines, commitments, and controlled documentation standards
Review controlled documents for compliance, consistency, and technical accuracy
Advise Quality Assurance auditors and operational teams in preparing quality-related information for sponsors, auditors, and regulatory inspectors
Leadership, Influence, and Project Management
Serve as a key internal resource and subject matter expert for QI management activities
Influence stakeholders and gain alignment on complex quality-related issues
Lead medium-scale and support large-scale QI Management or Corporate Quality projects involving moderate risk and resource complexity
Establish and maintain strong working relationships with internal and external stakeholders
Additional Responsibilities
Represent QI Management in internal or external forums as assigned
Support quality-related activities at the account or project level when required
Perform additional quality-related duties as directed by management
Travel may be required (approximately 15%)
This role does not include direct people management responsibilities
Required Experience
8–12 years of relevant experience in Quality Management, Quality Risk Management, or Regulatory/Clinical Quality within the pharmaceutical, biotech, or CRO industry
Demonstrated experience managing quality issues across clinical, laboratory, and/or manufacturing environments
Proven expertise in GCP, GLP, and/or GMP compliance frameworks
Strong background in leading root cause analyses, CAPA management, and quality risk mitigation initiatives
Educational Qualifications
Bachelor’s degree (BA/BS) in Science, Healthcare, Life Sciences, or a related discipline
Equivalent combinations of education and relevant professional experience may be considered
Required Skills and Competencies
Comprehensive knowledge of global quality systems and regulatory requirements
Strong analytical and problem-solving capabilities with the ability to address complex, non-standard issues
Demonstrated project management and stakeholder management expertise
Excellent interpersonal, communication, and presentation skills
High attention to detail with strong organizational and documentation skills
Ability to work independently, proactively, and manage multiple priorities under tight timelines
Advanced proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Customer-focused mindset with the ability to assess and respond to internal and external quality needs
Why Join Syneos Health
Opportunity to influence quality strategy across global clinical and corporate operations
Exposure to complex, high-impact quality risk management initiatives
Strong emphasis on professional development, leadership growth, and continuous learning
Inclusive, diverse, and collaborative work culture
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000+ sites and 675,000+ clinical trial participants worldwide
Additional Information
This job description is not exhaustive and responsibilities may evolve based on business needs. Equivalent education, skills, and experience may be considered. Syneos Health is committed to equal employment opportunity and compliance with all applicable global employment regulations, including disability accommodation requirements.
Job Summary
The Principal Professional – Quality Risk Manager provides strategic oversight, consultancy, and leadership for quality issue management across the organization. This role leads root cause analyses, drives corrective actions, supports regulatory compliance, and partners with internal and external stakeholders to ensure quality excellence across clinical and corporate services.
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