Director, Team Lead, GCP/PV QA (BB-DE2B5)
Found in: Neuvoo DK
Genmab’s pipeline of antibodies is growing and we are now looking for a Director, Team Lead GCP/PV QA to join the QA Team at our Headquarters in Copenhagen.
In this new established position, you will work in a multidisciplinary international QA team to ensure compliance to industry standards and regulations. As Director, Team Lead GCP/PV QA you will both be responsible of managing a small team of GCP/PV QA employees as well as work operationally on assigned development projects to maintain the required QA oversight.
In addition, you will be responsible for identifying, prioritizing and addressing improvement areas for the GCP/PV QA area in collaboration with Head of QA and other key stakeholders. You will be a part of the QA management team ensuring collaboration between the different QA areas and overseeing our global Quality Management System. In this function you will also work closely with our Clinical Operations and Pharmacovigilance & Drug Safety groups to ensure common understanding of strategy and expectations and handling of day to day quality issues.
The position reports to Head of QA located in Denmark.
The responsibilities of the Director, GCP/PV QA will include, but not be limited to:
Team management of the GCP/PV QA team currently consisting of 5 employees
Short- and long-term goals for the GCP/PV QA area (organization, processes, systems) in alignment with the overall Quality Management System
Ensure compliant and effective processes for clinical/pharmacovigilance vendor, site and system quality oversight, including audit planning and follow up
Liaison with clinical and safety areas to ensure compliant and efficient processes and systems and day to day operations
Be an active QA representative in both the early and late stage clinical development and for the marketed products, including oversight of GCP and Drug Safety activities globally
Plan, perform and follow-up on quality audits covering GCP/Drug Safety regulated areas both internally and externally and perform vendor evaluations
Represent QA in clinical project groups or clinical sub groups and participate in cooperation with partners and contractors as appropriate
In addition to this, the employee shall provide internal QA support in the organization and prepare/coordinate
Participate in GCP/PV inspections performed by national authorities
Clinical and drug safety/PV Quality Agreements
Participate in the development and maintenance of the existing Quality Management System (QMS) and associated clinical and pharmacovigilance SOPs
Participate in knowledge sharing by gaining and maintaining expert knowledge about new GCP and drug safety guidelines, clinical trials laws, legislations and practices, including informing relevant parts of the organization
Training and education programs related to quality aspects of GCP, drug safety and other relevant guidelines and regulations,
Oversight of the company’s clinical trials being conducted in compliance with clinical protocols, GCPs and other regulatory requirements
Experience with oncology will be beneficial
You hold an MSc in Pharmacy or a related scientific degree, or alternatively otherwise medically trained
You have more than ten years relevant industry experience in the GCP and Drug Safety areas from working in a Quality department
You have more than 5 years’ experience with managing teams
You have experience in SOP training
You have experience working in an EDMS system, such as Veeva Vault document management
You have excellent communication skills in both English and Danish, and a collaborative mind-set
Experience of oncology, late phase, pharmacovigilance, and/or first in human trials would be beneficial
Trained auditor is beneficial
Moreover, you meet the following personal requirements:
Exceptional leadership skills, with the ability to develop and communicate a vision that inspires and motivates staff and aligns with the overall QA strategy
Ability to develop staff including coaching, mentoring and performance management.
Ability to work successfully under pressure in a fast-paced environment and with tight timelines
A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders
Results-and goal-oriented and committed to contributing to the overall success of area of IT and Genmab
calendar_today11 hours ago