Senior Quality Assurance Associate

The Ideal Candidate:

• Solutions-driven
• Critical thinker
• Strong communicator
• Adaptable

What You'll Do:

• Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
• Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorisations in line with regulatory expectations.
• Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
• Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
• Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
• Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
• Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
• Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
• Coordinate product recalls and mock recalls as required.
• Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
• Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
• Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
• Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
• Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
• Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.

What You'll Need:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 2-5 years of experience in a Quality-related role within a regulated environment
• Practical experience in GxP Supply Chain, Production, and Quality Assurance, with knowledge of GMP, GDP, and the supply of unlicensed medicines (including distribution supply chains and unlicensed pathways preferred)
• Strong understanding of core Quality Management System processes, including risk assessments, deviations, change control, and supplier/customer management
• Ability to apply a risk-based approach to prioritize tasks effectively in day-to-day activities
• Proven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiatives
• Strong critical thinking and analytical skills, particularly in conducting and reviewing investigations
• Excellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlines
• Effective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervision
• Highly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency in Microsoft Office, particularly Excel