Sr Professional Quality Managament (GCP)

Sr Professional Quality Managament (GCP Exp Required)

Job Summary

Performs various activities (analysis, investigation, reporting, administration) related to GCP (ie Good Clinical Practice or Good Pharmacovigilance Practice) and related topics for Clinical departments.

Core Responsibilities

• Supports Clinical Monitoring (CM) teams through the duration of sponsor site audits
• Work with CM teams for the preparation of site audits, which includes performing quality checks on training documentation/TMF/study documents.
• Assist and work with CM teams during Audits and Inspections to determine underlying Issues, perform Root Cause Analysis (RCA), formulate appropriate Corrective and Preventative Actions (CAPAs), and implementing Effectiveness Checks
• Provides quality support and consultancy for Quality Management andfor Operations, as applicable
• Works within a specific knowledge area. May work outside area.
• Ensures commitments and timelines for assigned activities adhere to Syneos Health and customer requirements.
• Offers solutions to process and quality related issues and identifies process improvement opportunities
• Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
• Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
• Solves moderately complex problems and/or conducts analyses. Translates concepts into practice.
• Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
• Serves as a key resource within a business area or discipline.
• Anticipates and resolves problems, which may be moderately complex. Applies critical thinking to identify solutions to requests and problems
• Drives solutions for products, processes, and services
• Leads medium-scale Quality Management projects or programs with moderate risks and resource
• Normally receives little instruction on day-to-day work, general instructions on new assignments
• Represents Quality Management, as assigned
• Performs other quality-related activities as directed by management
• This position is not responsible for supervising employees
• Travel may be required (approximately 15%)

Qualifications

Education Requirements

Min/Preferred Education Level Description

Additional Qualifications

• BA/BS degree in science or health care or equivalent education and experience, plus some experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) preferred.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.
• Above average attention to detail and accuracy.
• Strong organizational, interpersonal and team-oriented skills.
• Ability to act independently and pro-actively.
• Significant project management and customer management skills.
• Ability to perform several tasks simultaneously to meet deadlines.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.