Our client is a leading Pharmaceutical organisation with office based in Dublin. They are currently seeking a QA Supplier Audit Manager to join their team. This role supports all the sites globally and ensures supplier quality across over 2,000 suppliers throughout their Operations supply chain. This role provides direction for the global supplier audit program as well as policy development for the pharmaceutical, biologics, combination products and medical device business. The successful candidate will manage a team of auditors responsible for compliance with US and foreign regulation requirements around the world and minimally include the Americas, Asia, Africa, Australia, European Middle East regions. Their leadership ensures activities are performed and documented in accordance with our clients policies/procedures and applicable quality and regulatory requirements intended to assure the effectiveness and safety of their products. This role is a senior influencing role that will sit on the senior management team – the successful person must have extensive experience in senior management/lead role. The role is based out of a Dublin office with 70% travel globally. The person will have also be managing our clients gobal audit team.
• Provide leadership for compliance and auditing professionals by being involved in annual succession planning, developing auditing competencies for the auditing function and provide training and development opportunities for staff members.
• Responsible for the overall supplier risk assessment and audit programs including development of audit processes, categorization of all suppliers based on the development and maintenance of a risk classification process for supplier criticality, development of the audit schedule to ensure the audits are conducted consistently across suppliers.
• Develop and implement a global supplier audit program for all 2,000+ suppliers including Third Party Manufacturers, Active Pharmaceutical Ingredients, excipients, and commodities which ensures quality products across the proprietary pharmaceutical, medical device, and combination products supply chain.
• Responsible for coordination and/or participation in due diligence activities in the support of acquisitions, divestures, co-marketing and/or in-licensing agreements in support of key business strategies.
• Review and approve audits performed by direct reports on audit team including development of mitigation plans for critical suppliers to external compliance to ensure no interruption of product supply.
• Responsible for effectively managing interactions and inspections for the global audit program by external regulatory agencies, internal auditing and customer audits. This includes full preparation of the audits, successful management of all inspections, coordination of observation responses & tracking commitments to closure.
• Participate in or coordinate mock inspection readiness activities to prepare suppliers that provide key materials to our clients’ business to ensure no significant risks prior to agency inspections.
• Partner with R&D Process Development, Purchasing, R&D Quality Assurance and Business Development to ensure that supplier selection will meet the manufacturing site needs. Responsible for influencing decision making regarding sourcing strategies, approval and contingency plans for supplier qualification.
• Determines if facilities, systems, and procedures are in accordance with established requirements and standards and assure that products are effective and safe for their intended use.
• Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments; participate in strategies to improve compliance to regulatory requirements/standards and assuring compliance to existing regulatory requirements to prevent regulatory and quality problems.
• Provide feedback in the form of audit observations, formulate recommendations and determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 10 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
• At least 10 years in the Quality Assurance, Supplier Control, Manufacturing, Laboratory, Technical Support, and/or validation.
• Desirable to have quality supplier experience and vendor management skills.
• Strong knowledge of global regulations, standards, and company requirements and must understand a variety of quality and operational systems that support facility, product design, development, production, distribution, installation, support and service, and understand the principles of quality management.
• Strong perceptual and analytical problem solving related to: removal of obstacles, setting of priorities, and ability to diffuse organizational conflicts involving people, resources, and/or facilities.
• Effective communication skills are essential with an ability to work effectively cross-functionally as well as with suppliers.
• Capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy company objectives.
• Strong project management and troubleshooting skills.
• ASQ Certification or other international certification desirable.
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256