- Our company is an exciting new biopharmaceutical company, with Headquarters in the US.
- We plan to be the credible partner in progressive, non-viral Liver Diseases to physicians, patients, payers and the broader scientific community.
- As company develops towards commercialization, we are creating a European organization full of people who are committed to bringing new innovation in Liver Diseases. We currently have an interim contract opportunity for an exceptional GCP/PV QA Manager, EUCA.
- The position of will be responsible to assess compliance with company standard operating procedures, GxP, European regulations, local regulations and guidelines, and clinical study protocols. Responsibilities include performing audits of internal systems, supplier, and of clinical trial sites.
- The role participates in the development, implementation and maintenance of the corporate GCP and PV Quality Management System and training program.
- This is a cross functional position that works with company personnel in many other departments, in a collaborative nature as an internal consultant on regulatory topics and interpretations. Strong communication skills (written and verbal), with the ability to build internal and external relationships.
- Develop and maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted by company in Europe.
- Actively lead or assist activities in the areas of Internal Quality Audits, CAPA, Quality Management Reviews, and Quality Audits. Audits likely to include clinical investigator sites, vendors, trial master files, internal GCP systems.
- Participate in solving GCP and PV compliance issues within Quality Assurance.
- Lead (GCP/PV) auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
- Assist with management of contract auditors.
- Prepare company and clinical sites for government regulatory agency visits to include local and potentially foreign government agencies; participate as Subject Matter Expert during regulatory GCP inspections
- QA Approval of company clinical/PV SOPs, protocols and reports.
- Maintain all associated department spreadsheets, tracking of audit findings, and audit files as applicable.
- Work with CROs to create quality agreements, ensure quality standards are met, and resolve issues promptly and effectively.
- Report significant clinical quality deficiencies and/or risks to QA management.
- Coordinate joint efforts in training company staff on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
- Accountable for accuracy of audit findings.
- Conduct follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
- Perform other related duties as assigned.
REQUIRED KNOWLEDGE AND ABILITIES:
- Ability to lead and coordinate diverse audit teams.
- A strong understanding of GxPs and an ability to apply them to clinical research and/or related processes is required.
- Inspection experience in hosting regulatory authority inspections.
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven negotiation skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
- Bachelor’s degree in science or equivalent.
- Significant experience in conducting GCP/PV Audits (QA experience in the Pharmaceutical industry required).
- Auditor qualified highly desirable.
- Being a part of building company's International organization from the outset is a unique opportunity.
- This role will, however, demand an ability to work strategically and operationally in equal measures.
- The position provides high visibility and growth opportunities for talented individuals who would like to accelerate themselves in a growing organization.
- Excellent remuneration on offer.