Global Quality Lead GCP Auditing and Compliance - REMOTE

Proclinical is seeking a remote Global Quality Lead GCP Auditing and Compliance for leading pharmaceutical company.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Lead and/or participate in the development of the risk based GCP audit program through evaluation of elements of the company's 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).
• Prepare, support and follow-up on GCP audits performed on behalf of the company's 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 the company's audit processes and standards.
• 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.
• As required, 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.
• 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.
• 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.
• Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and global quality standards.
• Participate in medium-long term projects within competence.
• Lead improvement initiatives, and where relevant, create and own the support in Policies and standards, oversee their deployment including training material.

Skills and Requirements:

• 5-10 years of background, knowledge, and experience of the (bio)Pharma industry and applicable technical aspects of the business.
• Minimum of 5 years' experience performing GCP related audits.
• Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP-related areas.
• 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.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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