Director, Quality GMP GDP - Europe - Home-based
Location: England, UK
Requisition Number: 5924
Position Title: Director, Quality GMP and GDP
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 3000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What you will do
- Ensures Depots work supporting Worldwide pharmaceuticals research activities are conducted in compliance with Good Distribution Practices (GDP), Good Storage Practices (GSP), Good Manufacturing Practices (GMP), EU Directives, International Conference on Harmonization (ICH) and Worldwide Policies and Procedures, as applicable
- Responsible for the GMP and GDP compliance of Depots and key vendors activities
- Manages QA liaison between designated vendors, Worldwide and Sponsors
- Conducts Vendor performance monitoring and ensures compliance to the Quality Agreement
- Conducts scheduling, planning, managing, facilitating and follow up of Sponsor audits of Worldwide depots
- Performs GMP, GDP and GCP audits and ensures the audits are reported and CAPA plans implemented to provide assurance of compliance with processes, regulations, guidelines, and agreements. Audits may be part of the internal audit or external vendor programs.
What you will bring to the role
- Demonstrates good organizational skills and critical decision-making skills
- Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
- Demonstrates skillset for being resourceful, managing conflict and negotiating
- Demonstrates a strong aptitude for facilitating group or project initiatives and building team unity
- Works with a sense of urgency; ability to recognize time sensitivity
- Demonstrates a good understanding of GMP, GDP, GCP principles and processes for clinical trials
- Demonstrates the ability to work collaboratively with cross functional stakeholders
- Demonstrates an excellent understanding of clinical research principles and processes for clinical trials
- Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators
- Possesses (broad) expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
- Excellent understanding of the principles for GMP, GDP and GCP regulations and guidelines.
- Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
- Previous experience with participating in regulatory inspections: FDA, MHRA, Health Canada, EMA or other international Regulatory inspections for GMP, GDP and GCP.
- Has experience with manufacture and release of IMPs for clinical trials globally, including EU requirements for QP release.
- Has experience of management and Quality oversight IMP supply to clinical trial sites.
- Possesses excellent experience in performing QA Audits, specifically GMP, GDP, GCP and CSV for each type Audits
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Director, Quality GMP GDP - Europe - Home-based
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: London, GB