Global Quality Lead GCP Auditing and Compliance - 7710

Interested ? Don’t hesitate to contact us !

megane.libert@professionals.randstad.be / julie.licoppe@professionals.randstad.be

• 
  Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP-related areas
• Experience in leading full range of GCP audits for internal processes/units and external partners or vendors, and in managing/hosting regulatory inspections or third-party audits with depth of understanding of the theory and practice of quality management
• Experience with any of the following in clinical trials is advantageous: Decentralized and/or Hybrid Trials, Wearables, Digital Diagnostics, and/or Digital Biomarkers
• Experience with application of regulatory requirements associated with the qualification, validation, implementation, use and life-cycle management of digital systems, tools and applications
• Minimum of 5 years of auditing, 5 years Clinical and/or a combination of the two
• In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations
• Familiarity with statistical principles and data analysis
• Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others
• Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
• High level of personal integrity with a strong commitment to patient welfare and ethical behavior
• Fluent in written and spoken English. Additional language skills would be an advantage
• Able to travel nationally and internationally as business necessitates, 30% of time on average
• Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility
• Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with external inspectors and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients
• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process
• Ability to proactively identify, assess, mitigate and manage potential risks to add value for patients and maintain reputation
• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations
• Ability to cope with stressful situations and drive issue resolution and decisions
• Excellent planning and organizational skills
• Structured approach
• Ability to build partnerships internally and externally
• Ability to navigate in the grey zone with the right sense of risk appetite, smart risk-taking behaviors and values
• Ability to apply change management principles and practices, to promote an environment of effective people engagement and efficient transition/adoption of changes

Consultancy

We offer an attractive salary with extra-legal advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate is freelance is also possible

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.

Job summary:

Global Quality Lead GCP Auditing & Compliance’ implements a Good Clinical Practice (GCP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP Quality Systems. The incumbent is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as Global Quality Management System; and that compliance risks are appropriately identified and mitigated.

Having the End-to-End view in mind, a close partnering is required:

• Within the Quality Organization (e.g. Early & Dev Solutions Quality Management; Quality Systems & Intelligence, and other auditing teams within Quality Auditing & Compliance, etc.)
• With Stakeholders outside the Quality Organization (e.g. Global Clinical Sciences & Operations, Global Clinical Development, Statistical Science & Innovation, Rare Disease Organization, etc.)
• With International Regulatory Authorities through Inspections

She/he is also responsible to provide input and advice to processes and areas impacted by GCP with respect to the requirements of global and local regulations, guidelines and industry best practice; and is therefore well-connected externally (e.g. Industry Forums, Associations, etc.) in order to stay abreast of global regulatory and industry trends.

Major accountabilities:

Internal & external auditingiInspections:

• 
  Prepare, support and follow-up on GCP audits performed on behalf by external vendors and/or consultant auditors; as per established process, contracts and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf (main accountability)
• Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management
• Lead and/or participate in the development of the risk based GCP audit program through evaluation of elements of the quality system and their effect on the overall state of compliance of the system
• Perform GCP audits as per annual audit program (investigator sites, vendors, systems,… according to established audit strategy)
• Perform GCP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships
• Perform due diligence GCP audits of potential company or asset acquisitions, as required
• Support the preparation, hosting and follow up of Regulatory Authority inspections related to clinical activities, in collaboration with the Early and Dev Solutions Quality Management team.

Drive insights for through data:

• Ensure timely and accurate input of audit and inspection data in Audit Management Tool
• As required and in collaboration with Quality Auditing Specialists, issue KPIs and dashboards that allow proper identification, follow-up and review of trends; providing a comprehensive summary and analyses of the comparative risks and outcomes across the GCP quality system
• Contribute data and feedback to GCP-relevant internal stakeholders (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status