Overview
Freelance Associate Director, Quality Assurance (GCP Auditor) (0.8-1.0 FTE) at TFS HealthScience.
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Hybrid in Warsaw, Poland / Lund, Sweden or home based in the UK, Italy or Portugal.
About this role
As part of our Quality and Compliance team you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Associate Director, Quality Assurance (GCP Auditor) works closely with the Senior Director of Quality Management and deputises for them in all areas. They will have line management responsibilities.
The role is capable of independently conducting work related to the development, improvement and daily management of the TFS QMS, managing the Quality Management System and documentation. They will manage the Annual Audit Plan and tracking of all audits, and oversee the recording of issues (including complaints and serious breach), managing CAPA and Computerised Systems Validation. This person has broad experience in clinical research and quality management and can provide support and advice across this area.
Key Responsibilities
AUDIT:
* Ensure the Annual Audit Plan is prepared, followed and maintained along with the Audit Progress Report.
* Track all audit types and ensure timely completion.
* Prepare, conduct and follow up on internal and external GxP audits.
* Support and guide operational staff in preparing for customer audits.
* Host / facilitate customer audits of the company and/or projects.
* Review and approve audit reports for other quality management personnel and provide advice/direction as required.
* Act as Quality Lead Auditor when applicable.
INSPECTION:
* Assist in preparing investigational sites for regulatory inspections, as required.
* Support and guide operational staff in inspection preparation, analyze risks and develop readiness strategy.
* Provide training/preparation to backroom support team; manage team during inspections.
* Host regulatory inspections for clients, as required.
* Host and manage regulatory inspections of TFS, as required.
QUALITY MANAGEMENT SYSTEM:
* Oversight, management and support of Quality Issues including review and approval of Risk Reviews.
* QI and Audit/Inspection CAPA including review and approval of CAPA plans; closure and effectiveness verification; Final QA approval of CAPA.
* Oversight and management of Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations as appropriate.
* Contribute to continuous improvement of the organisation and development/updating of the TFS QMS; ensure teams receive facilitation to prepare/update QMS documents.
* Develop and update quality management QMS documents as required.
SUPPORT:
* Provide quality management advice and support to internal staff and departments.
* Ensure continuous audit readiness, regulatory inspection support and monitoring.
VENDOR MANAGEMENT:
* Ensure all GxP vendors are assessed for clients or TFS; inform Vendor Management of issues/complaints and work to resolve them.
METRICS:
* Responsible for audit metrics and assisting with Quality Management metrics as required.
CLIENT INTERACTIONS:
* Host Quality Committees with TFS business units; provide quality management advice and support to external clients; participate in client visits/meetings as required.
BUSINESS DEVELOPMENT:
* Assist with proposals and costings including quality management; participate in customer visits and presentations when required.
MISCELLANEOUS:
* Review MSAs/Quality Agreements to ensure compliance; oversee RFIs and RFPs; act as trainer for Quality Management and TFS staff as needed; prepare Regulatory Intelligence Newsletter quarterly; maintain knowledge of applicable regulations and GxP standards; participate in internal meetings and liaise with other departments as necessary; other tasks as delegated by the Senior Director Quality Management.
QUALIFICATIONS
* University/college degree or equivalent industry experience.
* Awareness of global/local industry trends, policies and regulations in clinical trials and pharmacovigilance.
* In-depth knowledge of GxP (including CSV) regulations and guidance; previous auditing experience with thorough knowledge of GxP compliance; knowledge of GxP-regulated computerized system validation.
* Good computer skills (Word and Excel); ability to work independently; strong planning, organization and problem-solving abilities.
* Fluent in English, both written and verbal; several years’ experience in clinical research (e.g., monitoring, data management, drug safety, training).
* Five to ten years’ experience of auditing in two to three GxP areas; willingness to travel internationally to audit sites.
* Membership of a quality association (e.g., Research Quality Association) is advantageous.
* For candidates based in Italy: compliance with Italian MoH Decree dated 15 November 2011; protected categories under art. 1 L. 68/99 are welcome.
What We Offer
We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in patients’ lives.
A Bit More About Us
Our journey began over 29 years ago in Lund, Sweden. We are a global CRO delivering clinical research services across 40+ countries with over 800 professionals, in therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values are Trust, Quality, Passion, Flexibility, and Sustainability.
Together we make a difference.
Seniority level: Not Applicable
Employment type: Contract
Job function: Quality Assurance; Industries: Pharmaceutical Manufacturing
Get notified about new Associate Director Quality Assurance jobs in Hamburg, Germany.
#J-18808-Ljbffr