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Form of workJob Description
?Remote Position+
? JOB SUMMARY
Describe the primary purpose of this role as well as the Geographical Product (Global/Regional/Local) and any regulatory responsibilities
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 ***s clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as ***s 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
Describe the main accountabilities for this role including significant tasks, responsibilities and projects
? Internal & External Auditing/Inspections:
Prepare, support and follow-up on GCP audits performed on behalf of *** 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 of ***.
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.
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.
Support GCP audits as per annual audit program (investigator sites, vendors, systems, according to established audit strategy) or for purposes of qualification prior to contractual relationships.
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 in *** (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status
? Compliance Issues:
Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
Escalate Critical Compliance risks/issues to Quality Auditing & Compliance Leadership.
Upon the request of/with the approval of Quality Auditing & Compliance Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications)
? EDUCATION & QUALIFICATION
Education & experience necessary for this role
Education Level
Describe the minimum level of education necessary for this role:
? Bachelor's Degree
? Master's Degree
? Ph.D.
? Law (J.D.)
? Medical Degree (M.D.)
? Other (Describe): Auditor Certification is a Plus.
Sciences Certification/Registration Preferred (e.g. medical, pharmacy, nursing, public health, etc)
Other Certification
? Certification (Describe):
? Registration (Describe):
? Licensure (Describe):
? Other (Specify):
Experience
List the type and length of experience
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 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.
? COMPETENCIES
Include specific skills, behaviors and knowledge necessary to meet the objectives of the role
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.
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 ***'s reputation.
Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses aProductst 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
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