Senior Or Executive Director, Quality And Compliance

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.
Join Our Team as a Senior or Executive Director, Quality and Compliance - home based in the UK, Spain, Italy, Germany or Portugal.
For candidates based in Italy - w e welcome applications from candidates belonging to protected categories under art.
1 L. 68/99.
About this role As part of our Quality Assurance  team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Senior or Executive Director, Quality and Compliance is responsible for ­­­­­­­­­­­­­­­­­the Quality Assurance department, and Quality & Compliance direction across TFS, and will work according to company policies, SOPs and regulatory requirements.
Responsible for strategy, performance/delivery, compliance, and operational results of the department.
Actively participates in company management, planning and strategy design.
Key Responsibilities:  Leadership and Management: Provide strategic leadership and direction to Quality Assurance department Responsible for KQI and metrics for Quality Management Coordinate and oversee that global procedures such as Standard Operating Procedures are available, up to date and compliant with appropriate guidelines and legislation such as ICH, GCP and EU/US Directives.
Re-develop processes and practices to optimize compliance, consumption and efficiency.
Act as a Business System and Business Process Owner as delegated.
Overall leadership and line management for assigned staff and department, including resource planning, recruitment of new staff, performance review, training, disciplinary procedures and administrative activities.
Oversee time reporting and expenses.
Coach, support and mentor staff.
Develop and plan training as necessary, plus contribute to individual career development and goal setting.
Ensure succession planning by developing skills in staff to ensure good coverage and excellent performance for all Q&C activities, audit/inspection and sales representation.
Ensure that global operational deliverables are conducted in accordance to TFS quality standards.
Ensure any company initiatives are measured, tracked, and completed on time, with clear return-on-investment.
Support cost model development, pre-sales events, RFP, RFI, and post-award input (e.g.
MSAs etc.)
in relation to Quality & Compliance Provide quality management advice and support to all internal staff and departments Working constructively and responsively with Heads of Departments, senior staff, and other partners to better achieve company goals and create a positive working environment Host Q&IS Council meetings on a quarterly basis.
Audits: Responsible for preparing and monitoring compliance to the Annual Audit Plan Responsible for tracking all audit types and ensuring all are completed Prepare, conduct and follow up on internal and external GxP audits Responsible for hosting / facilitating customer audits of the company and/or projects Review audit reports for other quality management personnel and provide advice and direction as required Inspections: Responsible for hosting and managing regulatory inspections of TFS Assist in preparing investigational sites for regulatory inspections, as required Host regulatory inspections for clients, as required Quality Management System: Responsible for the management of the eQMS including all types of Quality Issues and CAPAs Contribute and coordinate so that Complaints, Potential Serious Breach and Potential Fraud and Scientific Misconduct investigations are finalized in compliance with TFS applicable SOPs.
Responsible for the development and improvement of TFS Quality Management System Responsible for ensuring all teams across the organisation receive appropriate facilitation to prepare new and update all types of QMS Documents.
Responsible for developing new and updating quality management QMS Documents, as required, and ensuring high quality in all published SOPs, policies and other documentation inline with appropriate guidelines and legislation such as ICH, GCP and EU/US Directive.
Training and Information: Deliver or coordinate delivery of training for Quality Management and all TFS staff for Quality & Compliance matters Responsible for ensuring Regulatory Intelligence is maintained and disseminated to the whole company (excluding Regulatory Process information).
Maintain excellent knowledge of applicable regulations and company GxP standards and procedures Other Quality & Compliance tasks: Responsible for ensuring all client or TFS GxP vendors are assessed Responsible for informing Vendor Management when issues/complaints are raised and working with Vendor Management to resolve these Other activities as delegated Qualifications:  University/college degree in life science or equivalent Minimum 10 years' experience in clinical research, (e.g.
monitoring, data management, drug safety, training, etc.)
Minimum 10 years' experience of auditing in two to three GxP areas Minimum 10 years in leadership role.
Excellent knowledge of GxP regulations and guidance.
Awareness of global trends, and government policies in the clinical trials area.
Experience in driving the quality and compliance within CROs and their regulatory requirements Strong leadership skills, problem-solving and team management Ability to deal effectively with inspectors, sponsors and internal customers at all levels Willingness and ability to travel Excellent English verbal and written communication skills.
Fluency in other languages will be considered as an advantage What We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients A Bit More About Us Our journey began over 27 years ago in Sweden, in the city of Lund.
As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future.
Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization.
They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.
By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence.
This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.