At the moment I am looking for a GLP specialists for one of my biotech clients in Belgium, the role is completele remote!
We are looking for a specialist to suppor Preclinical Quality Risk Management with a focus on GLP (GOOD LAB PRACTICE)
This position will help enable end to end quality risk management for R&D business partners performing or outsourcing GLP work to promote submission success and protect approval status.
The role includes proactive risk identification, assessment and mitigation at the level of external service providers, internal GLP-related processes or programs in close collaboration with business partner functions such as within Bioresearch quality and compliance for Nonclinical Safety.
• Support the management and execution of the GLP internal and external Service Provider (ESP) integrated quality risk management framework in collaboration with key stakeholders.
Key responsibilities include support for:
1. Maintenance of GLP universe (internal and ESP) across = R&D.
2. Identification of systemic risks related to GLP quality management systems (internal and ESP) and oversight processes with input from different angles including Health Authority information, performance monitoring, audit findings, business partner strategies and insights, evolving regulatory requirements and trends etc.
3. Collaboration with cross-functional preclinical development teams to assess identified risks and develop risk mitigation activities.
4. Ensuring appropriate risk monitoring, oversight and communication.
5. Capturing key risks and mitigation plans in a risk management system and assure all actions are driven to resolution
• Support development of the master audit schedule and scoping of GLP audits as requested from BRQC QA
• Help address quality components related to qualification of GLP ESPs in support of the overall sourcing strategy
• Contextualize key quality insights to primary stakeholders and provide quality consultancy
• Support timely management of significant quality events related to internal and ESP contractual services in collaboration with relevant preclinical functional teams including but not limited to formal escalation, support of CAPA development and/or overseeing execution of risk management activities
• Provide quality input into governance models led by key GLP stakeholders to assure operational management is assessed for potential quality impact. Facilitate risk mitigation activities as needed to address quality concerns that arise from operational governance models
• Support ESP components of integration plans following a license or acquisition deal
- BA/BS required, MA/MBA preferred
- Active expertise in GLP (min 8 years)
- In depth knowledge of global OECD and FDA GLP regulations and guidelines
- Familiar with different GLP study types and components such as toxicology, pathology, bioanalysis, genetic toxicology, toxicokinetics in a global multisite setting.
- Basic knowledge of GMP
- Collaborative and open attitude, customer oriented, diplomatic and problem-solving skills, familiar with risk-based thinking.
- Risk management experience is preferred.
- Must be proficient in English language
- Must be proficient with common computer system applications (Sharepoint, Word, Excel, Powerpoint)
- Awareness of quality requirements in Discovery and non-GLP development, GCLP and of Animal Welfare is preferred.
Project Start Date
- Preferably April or May
- 8 months (extension expected)
If you are interested in the above description, please apply with your CV.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at email@example.com