Head of GxP Audit and Inspection - Mechelen,BE/Basel,CH
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium, France, the Netherlands, Switzerland, Italy, Spain, Germany, UK, Sweden, Denmark, Austria, Norway and 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 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.
We are looking for an Head of GxP Audit and Inspection - Mechelen,BE/Basel,CH
Scope of the job
You provide strategic direction and leadership for overall GxP Auditing activities to ensure compliance with company policies, industry standards, and applicable regulations. You show and 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.
Your principal accountabilities:
- Set strategy and oversee implementation of a Global GxP Risk based Audit program at Galapagos in collaboration with the Quality Management organisation and business partners, including but not limited to:
- Risk-Based Master Audit Plan
- Vendor audits
- Internal process and system audits
- Managing external audit from partners
- Provide leadership to support Health Authority inspections and shape general company inspection readiness
- Serve as quality voice in identifying and communicating trends from audits and inspections for continuous improvement and risk mitigation.
- Support the business with vendor quality qualification, on a risk based approach
- Line Manager and Talent Development of GxP Audit & Inspection Management Team
- Lead in the risk-based approach in the development of the Global Master Audit Plan with contribution from relevant stakeholders
- Provide leadership for the team to oversee and execute audits of GxP vendors and to perform internal process and system audits
- Partner with stakeholders to contribute to mitigate the Compliance, Regulatory and Quality risks through the follow up on the above-mentioned audits or inspections, confirmation of appropriate CAPA as well as timely implementation and closure,
- Provide support for Health Authority Inspections (preparation, support and follow-up activities).
- Implement inspection preparedness to assure GxP compliance of internal operations including mock inspections. Establish quality metrics for audits and inspections and acts appropriately based on these metrics in preparation for pre-approval inspection by global regulatory authorities. – something on connection with business to enable this
- Identifies risks/communicates gaps to the Quality Management team and Senior Management, as appropriate.
- Lead/coordinate internal quality improvement initiatives as appropriate.
Who are you ?
- 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.
- 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.
- Fluent in English reading, writing and speaking.
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…!