Associate Director – Corporate Quality
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Gurugram • India
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Job Level
About the role
- Oversees the conduct of audits and conducts audits in accordance with QA SOPs and WIs
- Responsible for generating own and reviewing and approving others’ audit reports
- Prepares for and hosts or supports customer audits in accordance with QA SOPs and WIs
- Coordinates responses to customer audits of computer system validation and data integrity, and resolves issues with customers, where applicable
- Plans and provides strategies for assessing readiness of Syneos Health offices for potential Regulatory Inspections and conducts such assessments (e.g. develops a program for and conducts ‘mock inspections’)
- Develops and delivers inspection readiness training to staff
- Prepares for and hosts or supports Regulatory Authority Inspections in accordance with QA SOPs and WIs
- Coordinates the preparation and support activities for inspections by Regulatory Authorities, including compilation of any pre-inspection required information
- Communicates findings from customer audits and Regulatory Authority Inspections of Syneos Health promptly to appropriate Syneos Health personnel and provides support on root cause analysis, corrective and preventive actions
- Provides consultancy on computer system quality and data integrity related matters
- Proposes strategies for improvements to quality and compliance of Operations and services
- May participate in and direct activities related to department staff operations such as interviewing and selection, professional development, performance management, employee counseling and separations
- Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods
- May have line management responsibilities for staff members
Requirements
- Requires a Bachelor’s degree in a science/health care field or equivalent
- Significant experience and expertise in all aspects of GxP quality assurance auditing
- Previous experience in the conduct of multiple audit types (e.g. vendors, computer system validation, trial master files, clinical data science, safety reporting, and laboratories)
- Previous knowledge of Software Development Lifecycle, IT Infrastructure and information security
- Excellent knowledge of GxP regulatory requirements
- Computer literacy commensurate with job requirements (Microsoft Office suite; basic Share Point proficiency)
- Able to act independently and proactively
- Above average attention to detail
- Able to handle multiple tasks to meet timelines in a dynamic environment
- Strong organizational, presentation and interpersonal skills
- Excellent team building skills
- Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds
- Ability to negotiate and provide constructive feedback
- Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP quality assurance auditingcomputer system validationSoftware Development LifecycleIT Infrastructureinformation securityaudit report generationroot cause analysiscorrective and preventive actionsinspection readiness trainingdata integrity
Soft Skills
attention to detailorganizational skillspresentation skillsinterpersonal skillsteam building skillsnegotiation skillsconstructive feedbackcommunication skillsindependenceproactivity