Do you have profound knowledge of and experience in OECD and FDA Part 58 regulations, in GLP toxicology and bio-analysis testing ? You have experience with vendor qualification and oversight ? You can work independently, oriented towards obtaining results and solving issues ? Our client, a global pharma company, is looking for your expertise ! This position can be done entirely remotely.
Job description
Our client is recruiting for a consultant to support Preclinical Quality Risk Management with a focus on GLP (GOOD LAB PRACTICE)
This position will help enable end to end quality risk management for Client 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, Nonclinical Safety, Discovery Sciences, Client Biotherapeutics, Plant and Material Protection, Ecotoxicology, Viral Vaccines, Environmental Health and Safety.
Responsibilities
- Support the management and execution of the GLP internal and external Service Provider (ESP) integrated quality risk management framework in collaboration with key Client and ESP stakeholders.
Key responsibilities include support for:
1. Maintenance of GLP universe (internal and ESP) across Client R&D
2. Identification of systemic risks related to GLP quality management systems (internal and ESP) and/or Client's 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
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Profile
- 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.
Benefits
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17551
