Quality Assurance Specialist at Xcene Research

Job Purpose

• To drive the quality of clinical trials conducted, for all phases of the trials, the Quality Assurance Specialist is saddled with providing insights, analyses and support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures within the region or globally assigned trials. Also, provides direction in support of audit and inspection programs, and the QA quality management systems.

Key Accountabilities

Quality documents (QDs)

• Support the implementation of a practical, user-friendly, compliant system for the management of the Xcene Clinical QDs.
• Support the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement).
• Support development of QDs for the CQA function.
• Review all other Clinical QDs for compliance with regulations, company policies, other QDs.
• Ensure availability of current QDs to all Xcene staff on an electronic platform.
• Provide controlled copies to external parties.
• Support gap analyses of processes.
• Support process improvement and QD optimization activities.

Training

• Support company approach for staff training by providing or coordinating training (e.g., GCP, QA, Risk Management, QDs).
• Support maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records).

Clinical trial support & optimization

• Replace CQA Leader or Senior CQA Manager at Extended Disease Team meetings when needed.
• Be an ad hoc member of Trial teams, attend meetings as needed, and review meeting minutes.
• Attend other meetings as required, in line with need/internal procedures.
• Act as GCP expert/consultant and provide expertise, support, and/or respond to questions from Clinical staff on GCP/QA questions.
• Provide support with interpretation of regulatory guidelines.
• Support CQA Leader input to QA section of Clinical Development Plans, where applicable.
• Identify potential risks in trial management activities and communicate these to the trial responsible and CQA Leader.
• Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at Xcene Research.
• Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits.
• Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations.
• Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.
• Assist with management of contract auditors.
• Assist in conducting vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.

Audits/quality control

• Provide input to Audit Plan from discussions/feedback with Trial teams.
• Support management of out-sourced audit activities, including liaison with auditee and Xcene Research contact, review of draft audit reports.
• Liaise with auditee for the completion of a Corrective/Preventive Action Plan (CAPA plan) and oversee follow-up and timely close-out of CAPA.
• Feed information into the tracking tool to be able to provide trends on audits and audit findings.
• Perform quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested).

Inspections (or external audits)

• Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection.
• Provide support to develop and feedback on the inspection CAPA.
• Feed information into the tracking tool for trends on audits and audit findings.

Risk management

• Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out.
• Support clinical staff to implement the deviation process.
• Support Risk Management Plans for clinical activities.
• Support risk management and risk mitigation activities.
• Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues.
• Ensure escalation to CQA Leader of major or critical quality issues or risks.
• Participate in regular CQA meetings to discuss QA/GCP issues and align/harmonize approach.

Skills

• Willingness to work with multiple supervisors in a matrix environment and to value the importance of teamwork.
• Ability to understand, apply, and explain concepts.
• Ability to work professionally with highly confidential information.
• Ability to lead and manage multiple responsibilities.
• Be willing to travel when necessary.

Knowledge and Experience:

• Minimal 1 year of experience.
• Must have thorough knowledge of clinical research concepts, practices, and FDA regulations, country local regulations, NAFDAC regulations, EU regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods. 
• Expertise in quality management with demonstrated ability to effectively manage multiple projects and people.
• Proactive problem-solving abilities and follow-through. 
• Ability to work in a very dynamic environment of scientifically driven biotech, with limited resources and able to plan and execute simultaneously, as well as ability to evaluate and resolve complex problems. 
• Self-motivated to maintain expertise in quality and GCP requirements and guidance to ensure that the clinical operations remain compliant with GCP and other global regulatory guidelines or laws.

Education and Qualifications

• Bachelor’s degree (or equivalent) level of qualification in Life Sciences, Pharmaceutical Science or related field or equivalent combination of education and experience.