Our client is a global leader in the Biopharmaceutical industry, committed to bringing Better Health and a Brighter Future to people worldwide. They are in 80 countries and regions worldwide and have over 200 years of experience. They are currently looking for a Complaints Senior Specialist.

The Role:

Key responsibilities include but not limited to:

• Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
• Timely management of the complaint processes to comply with corporate procedures, EU, and FDA regulations, ISO13485 and other regulatory requirements
• Escalate and participate in resolution of potential product deficiencies for all applicable products originating from a market complaint
• Liaise with Internal Stakeholders, Call Centres and service providers to ensure policies are aligned with the necessary regulations and standards.
• Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections, and complaint handling processes for all applicable products.
• Identify and drive continuous improvement to ensure a lean and compliant process.
• Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
• Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
• Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
• Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.
• Assure that all product complaints are investigated to the appropriate level within the required timeline.
• Send customer response letters where required.
• Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.

The ideal candidate will have the following:

• Minimum Level 8 Degree in Engineering / Science or related discipline
• 5-9 years' relevant experience in Quality Assurance or a GMP-related field within medical device, biotechnology, or pharmaceutical manufacturing or equivalent.
• Candidates must be able to think critically and make sound decisions.
• We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.

To apply for this role contact Déanna Healy - 0876369263 or send a CV directly to