Responsible for ensuring Bavarian Nordic facilities in Munich, Germany and Morrisville, NC, USA comply with relevant guidelines and regulations, as they relate to quality procedures and protocols. Responsible for managing the audit and inspection process, as well as the overall quality process, in accordance with GCP. Responsible for managing and expanding the Pharmaceutical Quality System, in the spirit of continuous improvement across Bavarian Nordic.
Management of GCP compliance:
Initiate and/or actively contribute to implementation of measures to maintain and improve GCP compliance in North Carolina and in Munich, Germany
Manage contribution to strategic/project planning, reporting and budget preparation within GCP
Oversee GCP audits performed (all trials)
Manage implementation and maintenance of GCP in North Carolina and in Munich, Germany
Responsible for authority inspections and client audits of the North Carolina site in collaboration with global QA
Manage and coordinate GCP Quality Assurance activities for North Carolina and Munich, Germany (e.g. audit planning and performance), and ensure that related quality issues are properly investigated and solved
Supervise QA consultants at the North Carolina site, if applicable
Oversee the GVP audits in close collaboration with QPPV in BN Munich
Responsible for data integrity and compliance within GCP/GVP
Perform internal audits as required by the “ICH E6 Good Clinical Practice: Consolidated Guidance, including audit reports and appropriately follow up on corrective and preventive action plans (e.g. training as necessary); ensure realization of BN’s Quality Assurance Program regarding GCP compliance for North Carolina and Munich
Perform site investigations, vendor (e.g. clinical laboratories, ECG provider, etc.) and CRO audits
Provide guidance and support to the respective departments in North Carolina and Munich regarding activities where compliance with relevant guidelines is required, such as writing and training of SOPs, as well as documentation of these activities.
Actively contribute to BN’s Quality system. Develop, implement and maintain the GCP audit plans
Training of staff in quality related issues
Remain current and up-to-date on projects within the company. Improve competency and knowledge in the area of vaccines regarding applicable relevant laws, regulations, and guidelines. Specifically, stay informed and up-to-date regarding GCP regulations through participation in seminars, conferences and workshops (e.g. DGGF)
Support BN-Denmark QA (Headquarter QA) regarding external auditing as applicable
Write, review, and approve SOPs and other relevant quality documents within Change Control and Deviations and CAPA reports in close cooperation with respective BN departments
Knowledge, Skill and Competency Requirements:
Demonstrated knowledge of GCP/GVP requirements in clinical research
Excellent analytical and strategic planning skills
Must have leadership experience in a high growth environment and the ability to delegate tasks as appropriate
Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously
Strong interpersonal, oral and written communication skills, including the ability to effectively communicate with all levels of personal
Ability to work accurately with close attention to detail
Work proactively and effectively in a fast-paced environment.
Ability to adapt to changes in company structure and responsibilities
Must possess a high level of personal integrity, excellent work ethics and respect for colleagues at all levels.
Must be ability to travel domestically and internationally up to 20% of time
Bachelor’s degree in related field required
Minimum of 5 years of experience in clinical research required
Minimum 8 years of experience with GCP environment required, including knowledge of GVP requirements