Head of GxP Audit and Inspection - Mechelen, BE, Leiden, NL or Basel, CH

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe and the US.

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 pioneer for patients. 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-happener’.

We are looking for a commercial Head of GxP Audit and Inspection - Mechelen, BE, Leiden, NL or Basel, CH

Scope of the job

The Director, GxP Audits and Inspections is a key member of our Global Quality Operations team. The role is accountable for establishing the strategic direction, program oversight & processes, and directing the operational outcomes for GxP inspections, audit program, and supplier qualifications. This critical and highly visible role provides one with a unique opportunity to build out the GxP Audit & Inspection program. This role will ensure compliance with applicable global regulatory requirements and alignment with company and quality objectives related to GxP audits, supplier qualification, and inspection logistics. As a key member of the Quality team, this role will heavily influence and support building a culture of quality mindset.
Provide strong leadership as well as expertise across several GxP areas and proven experience in managing GxP inspections in the R&D and/or Commercial setting.

You role

Audit Program

• Owns the integrated GxP audit process, including planning, engaging stakeholders & leadership, execution, and generation of reports for vendor / external audit programs.
• Liaise with the Quality organization to develop and manage the annual GxP Audit schedule, including external and internal audits and self-inspections.
• Manage and oversight of the auditing budget, inclusive of forecasting, and tracking.
• Oversee the execution of the audit schedule according to the plan.
  
  

Supplier Qualification

• Own the supplier qualification program/process & oversight that includes the partnering with Quality and functional representatives in the identification, qualification requirements, and selection of GxP suppliers.
• Establish tools, capture systems, and questionnaires with Quality and procurement to support pharmaceutical and device suppliers.
• Manage and oversee the approved supplier list.
  
  

Inspection

• Own and manage the backroom activities and inspection logistics process.
• Oversee & direct inspection readiness logistics strategy & activities for all GxP areas.
• Spearhead the inspection management processes, calendar, tools, software, templates, logistics, training, and oversight during all phases of an inspection.
  
  

General

• Owns processes and SOPs in the area of responsibilities. Partners with and influences key personnel to align and facilitate strategy, procedures, and processes harmonize.
• Promotes Quality and GxP awareness across the organization, including training initiatives.

Manage and lead a team.

Who are you?

• 10+ years of experience in early or late phase clinical research or a GxP regulated environment and 6+ years’ experience in quality compliance or assurance experience in GxP environments.
• A hands-on leader with previous managerial experience who leads by example inspires and empowers team members.
• Strong knowledge of GxP's (GLP, GMP, GCP, GVP)
• Managing inspection and related readiness activities are required.
• Proactive in identifying opportunities with a solid solution-minded approach and flexibility to emerging challenges.
• Strong collaborative, influencing, and interpersonal skills with excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management.
• Ability to prioritize competing activities and manage resources and budget accordingly.
• Ability to maintain and create professional networks with stakeholders internally and externally.
• Ability to understand and translate customer needs for innovative and creative approaches to quality management.
  
  

Skills, Knowledge & Abilities

Comfortable working independently

• Build and translate strategies into the process.
• Highly organized, results-driven, problem solver
• Superior written and oral communication skills and the ability to work with different levels of management.

Education (add qualification if relevant) & experience:

• PhD or Master in a life science field (Biology, Chemistry, or Pharmaceutical sciences) with 10-15+ years QA experience within biotech and pharmaceutical settings.

• A hands-on leader with previous managerial experience who leads by example, inspires and empowers team members.

• Must have demonstrated experience with GxP auditing. Vendor audit experience in a variety of vendor types is a must.

• Inspections and investigation experience are required.

• Ability to maintain and create professional networks with stakeholders internally and externally.

General skills:

• Current and strong working knowledge in several of GCP, GVP, GLP and GMP, CFR Title 21, Eudralex Vol 4 and regulatory guidances including, ICH quality, nonclinical, clinical, multidisciplinary guidance documents, and Eduralex Vol 4, Annex 11 & 21 CFR Part 11 compliance – with specific expertise in one or more
• The ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization, excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies.
• Strong interpersonal skills resulting in an effective (intra- and cross-departmental) team player.

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 biopharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!