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Associate Director, Corporate Quality
Syneos HealthProviding expert quality support based on a deep understanding of global GCP/GxP requirements. Collaborating with internal and external customers to improve quality and satisfaction at Syneos Health.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/ GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction.
- Provides quality oversight, support and consultancy for or within accounts, as assigned.
- Supports the internal account and/or operational teams on quality delivery and continuous improvement.
- Provides quality consultancy and support for project/program/functional/account level quality issues, audits, and inspections (e.g. support for audit/inspection preparation and response activities and inspection readiness activities) as outlined.
- Partners with the responsible person for account management (or key project/account team members) and the customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable.
- Investigates quality trends, potential risks and mitigations with key project/program/function and account team members.
- Supports Direct reports related to goal setting, problem resolution and decision making.
Requirements
What you’ll need- University degree and professional experience or equivalent.
- Experience in a global clinical research, pharmaceutical, or Biotechnology Company preferred.
- Thorough knowledge of drug development and ICH GCP Guidelines is necessary.
- Experience in quality management and/or process improvement is essential.
- Comfortable working closely with customers.
- Effective at critical thinking and conflict resolution.
- Effective strategic planning, communication, written, presentation and analytical skills.
- Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required.
- Experience working in a matrix team environment is preferred.
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture – where you can authentically be yourself.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality managementprocess improvementdrug developmentICH GCP Guidelinesaudit preparationinspection readinessquality oversightquality consultancycritical thinkingstrategic planning
Soft Skills
customer satisfactionproblem resolutiondecision makingcommunication skillspresentation skillsanalytical skillsconflict resolutioninterpersonal skillsteam collaborationorganizational skills