GVP/ GCP Audit Lead, Mechelen - BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville, Paris), the Netherlands (Leiden), Spain (Madrid), Italy (Milano) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a GVP/ GCP Audit Lead (Associate Director)
Scope of the job
Galapagos has been discovering and developing drugs over the last twenty years and is now ready to go commercial. To support the growth of the company, we are looking to strengthen the Galapagos auditing team with an experienced Pharmacovigilance (GVP) auditor with GCP experience.
The incumbent will be responsible for defining the audit strategy together with the Head of Global Audit, creating and managing global PV audit programs, conducting/supervising audits End to End and developing more junior auditors.
In this role, your principal accountabilities are to:
- Collaborate with the head of Global Audit, the Quality Management (QM) Team and business partners to define the audit universe & risk based audit strategy.
- Create and maintain global PV audit programs and GCP audit programs.
- Independently conduct complex global GVP and GCP audits for all phases of clinical studies, suppliers, systems and documents to assess compliance with Galapagos SOPs and applicable regulations and guidelines (e.g. ICH, EU Directives, US FDA, and National regulations), identifying compliance issues, communicating results to and educating auditees, project teams, and management.
- Provide GVP and GCP expertise (interpretation and guidance) to internal and external customers, proactively maintaining cognizance of current GxP standards.
- As subject matter expert, collaborate with other internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
- Manage audit activities (planning, execution and delivery) for less complex study and supplier audit activities, providing leadership and support to the auditors performing the audits.
- Undertake a variety of cross functional roles or assignments (lead or support) to further develop internal processes, acting as GVP/GCP expert.
- Actively lead or support regulatory inspections (and preparations for), as requested.
- Develop more junior staff.
Who are you ?
- Bachelor’s Degree or above
- Minimum of 8 years of relevant pharmaceutical Pharmacovigilance (GVP) and Clinical research/GCP auditing experience.
- In-depth knowledge of the applicable GVP and GCP guidelines and regulations, ICH Guidelines, Regulations and Guidances.
- Fluent in English.
- Excellent Interpersonal skills.
- Excellent oral and written communication skills.
- Able to navigate through a rapid changing environment.
- Passion for embedding quality within the organisation.
- Confident and adept in the use of computerized databases and other applications
Organizational skills, attention to detail, excellent planning and follow through.
- The position may requires approximately 20 % travel internationally.
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!