This temporary jobs require you to manage the risk-based quality assurance audit program, including:

• Create and execute QA audit plans
• Plan, track and oversee GxP audits
• Issue audit agendas, observations/recommendations, and final audit reports
• Provide suitable recommendations for internal audit observations. Ensure auditees deliver appropriate CAPAs and follow them through to closure. Escalate as appropriate, where resolution of internal audit findings is inadequate
• Ensure that audit results are formally recorded and reported and that corrective/preventive actions, if necessary, are documented
• Review and identify improvements that enhance the equality and clarity of audit reports
• Assist QA management in the development and implementation of procedures. Provide working practices to ensure continuous quality improvement
• Ensure compliance of  operations and initiatives with all applicable regulations and standards
• Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations
• Exercises judgement in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance
• Contribute to the information provided to QA management to summarise quality issues arising from audits and other related activities, as requested
• Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies
• Review of QA  reports, external publications, etc. as requested
• Maintain relevant knowledge of both local and international auditing and appropriate GXP requirements and developments as they impact Agenus’ SOPs and compliance with GXP and communicate these to QA management, as applicable
• Knowledge of EU GxP, US 21 CFR FDA regulations and International Conference on Harmonization (ICH)  regulations and guidelines is required

Work experience and Educational background

• B.S. in a science field (or equivalent degree)

• Minimum of 5 years of direct QA experience with at least two of those years as a lead auditor in a Pharmaceutical or GXP regulated environment

• Experience in regulated pharmaceutical, biological

• Expertise in identifying risks to quality and business during audit activities and to evaluate their magnitude and potential impact

• Ability to travel up to 40% of time, globally

Additional skills or experiences

• Ability to stay current with the international ICH guidelines, FDA regulations, and quality and regulatory standards, trends, rules

• Current working knowledge interpreting and implementing ICH, FDA, and other various local government regulatory requirements governing GCP/GLP/GVP operations.

• Excellent oral and written communication skills

• Ability to organise and manage multiple priorities

• Be flexible and prepared to perform other related tasks as assigned