LEAD AUDITOR, GCP
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area. The company headquarter is in Greater Copenhagen, Denmark with subsidiaries, production facilities and distributors worldwide.
Our client is looking to bring onboard a high-caliber International GCP Auditor/Clinical Quality Manager (Lead Auditor) to join the GQCM team. The role will be responsible for performing investigator site audits and supplier audits as well as internal GCP audits, independently or in close collaboration with other Lead Auditors at our client.
As QA partner to the Global Pharmacovigilance and Clinical Development organization, the role will take the lead on the planning, execution, reporting and follow up on audits while ensuring effective supplier management hereunder qualification of external collaborators and suppliers.
Lead Auditor, GCP
Senior Director, Global Quality Clinical & Markets
Apr. 50 days
Responsibilities & Tasks:
• Conducting internal GCP audits of Clinical Development systems and processes.
• Conducting external GCP audits of vendors, investigational sites and CRO’s to ensure that our client's studies are being performed and documented in accordance with the principles of GCP.
• Coordinating and analyzing audits conducted by third parties.
• Facilitating closure of audit findings, assisting with root cause analysis (RCA) and action plan development, driving corrective actions to completion and conducting effectiveness checks.
• Representing and supporting the Global Pharmacovigilance and Clinical Development organization during regulatory inspections.
• Supplier management - hereunder qualification of external collaborators and suppliers.
• Ensuring regulatory surveillance for GCP and impact to the Quality and auditing area hereunder providing guidance/direction to company Global Clinical Development staff on pertinent GCP standards to enable development of SOPs and compliant systems that fulfil GCP requirements for International and local Regulatory Agencies as well as ethics committees.
• Assisting with the development and conduct of GCP training for in-house and clinical investigational staff.
• Assisting with the coordination and implementation of inspection readiness activities.
• Advising Global Clinical Development on the implementation of effective, compliant, standardized processes and systems (QMS) that enable the company's clinical investigation- studies to be performed in compliance with relevant country Good Clinical Practice (GCP) Regulations.
• Drafting inspection readiness plans and coordinating implementation of inspection readiness activities.
Key success criteria:
• Seamless collaboration and interaction with internal and external stakeholders.
• Successful planning, conduct, reporting and follow up of internal and external GCP audits.
• Completing tasks and responsibilities to the highest professional standards while ensuring that all work is accomplished with quality and in accordance with company values.
Preferable M.Sc.-level degree within nature science or like (not a requirement).
English – fluent (verbally and written).
Ideal experience and competencies:
• 5+ years of experience within clinical development regulated areas including experience with Quality Management Systems and tools.
• Preferably experience as Lead Auditor within clinical development and/or pharmacovigilance (internal audits of HQ and affiliates and external audits of collaborators and suppliers).
• Sound understanding of Good Clinical Practices as interpreted by the global regulatory authorities.
Is a flexible and empathetic team player. Sees opportunities rather than limitations. Collaborates, shares information and works well with others with a view to obtain team objectives.
Possesses excellent oral and written communication skills in English. Communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep the recipients' attention. Produces written material, which is clear, fluent, precise and easy to understand for the recipients. Attentive to the needs of others when he/she speaks.
Proactive mindset and navigates smoothly across multiple organizational layers of stakeholders. Is able to establish and maintain relations with people at all levels – internally and externally – and makes people feel at ease.
Ability and willingness to quickly adjust to new situations in a continuously developing environment. Navigates smoothly when faced with late/last-minute changes in customer demands, requirements etc. Finds a way forward, reallocates resources, sets new priorities, and ensures alignment across the organization.
Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for oneself and for others.
Able to communicate with people from other cultures, relates to problems as seen from other cultures' perspective.
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Works systematically; organizes work and effort; is methodical in one's performance.
Makes rational, realistic and sound decisions based on the involvement of available facts and possibilities.
Is proactive and able to inspire others and is able to take own initiatives without hesitation. Actively seeks influence and starts up actions on own initiative.
Is independent, self-assured, has a realistic belief in own abilities to take suitable measures in the execution of tasks, expects success regarding own initiatives, able to maintain momentum in case of adversity.