Senior Quality Assurance Manager
hace 7 días
About Tfs Healthscience
Tfs Healthscience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
About the Role
As a Senior Quality Assurance Manager / Quality Assurance Manager, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. Your key responsibilities will include:
- Computer Systems Validation: Manage and lead all quality aspects of CSV and IT Security within Tfs. Prepare, conduct and follow up on internal and external CSV / Computerised Systems audits including system/process audits and vendor audits. Mentor and train Quality Managers in CSV and IT Compliance as appropriate.
- Client Interactions: Assist with business development of external quality and compliance services. Lead / attend client visits / client meetings when required.
- RFIs: Provide input into the quality section of RFI / RFP and quality assessments; maintain a library of questions and robust agreed answers.
- Audit: Prepare, conduct and follow up on all types of internal and external GxP audits. Peer review of audit reports. Support and guide operational staff in preparing for customer audits. Hosting client audits.
- Inspection: Preparing investigational sites for regulatory inspections, as required. Guide operational staff in preparing for inspections including analyzing risks and developing inspection readiness strategy. Provide training/preparation to the backroom support team; manage team during inspections. Host and manage regulatory inspections for clients, as required.
- Quality Management System: Facilitate teams from across the company in generating/updating any QMS Documentation; driving the process to ensure no QMS document expires. Support staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all quality events, ensuring all are completed on time and documentation is always suitable to share with clients as appropriate. Assist staff to prepare appropriate and robust CAPA Plans (for Quality Events) and track and manage these through to completion ensuring most CAPA are completed on the due date. Actively contribute to continuous improvement of the organization and development of routines to enhance the work at Tfs.
- Support: Provide quality advice and support to internal clients.
Requirements
To be successful in this role, you will need to have:
- Strong knowledge of GxP regulations and industry standards.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Ability to prioritize tasks and manage multiple projects simultaneously.
What We Offer
Tfs Healthscience offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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