Quality Assurance Compliance Specialist

Job Responsibilities:

• Work closely with the QA Compliance Manager to maintain compliance with global health authority regulations, industry standards (e.g., ISO), and internal SOPs.
• Promote a culture of quality, efficiency, and attention to detail.
• Provide support for Supplier Quality, Internal Audit programs, External Audits, Recalls, Complaints, Regulatory Intelligence Assessments, and Annual Product Reviews.
• Identify, assess, and resolve operational and quality-related gaps.
• Build and maintain strong, customer-focused relationships with internal teams, suppliers, and partners.
• Drive positive outcomes by collaborating with process owners and subject matter experts, even without direct reporting authority.
• Prepare, review, and manage supplier evaluation documentation, including supplier assessments, questionnaires, and audit reports.
• Oversee the development, review, and closure of Supplier Corrective Action Requests (SCARs).
• Draft and evaluate quality agreements between suppliers and the organization.
• Review material specifications and oversee internal audit planning and mitigation tracking.
• Assist with external/third-party audits, recalls, complaints, and annual product reviews.
• Conduct regulatory surveillance activities using the Redica platform.
• Effectively manage multiple projects in a dynamic, fast-paced environment.

Qualifications:

• Exceptional written and verbal communication skills, with the ability to clearly articulate complex issues to various audiences.
• Strong ability to work both independently and collaboratively, demonstrating excellent organizational and self-management skills.
• A minimum of 5 years of experience in the biopharma industry with increasing responsibilities in supplier quality management and/or supply chain quality.
• At least 5 years of experience in internal audit processes.
• A minimum of 2 years of experience managing recalls, complaints, and annual product review activities within the biopharma sector.
• Proficiency in industry-related computer applications, including SAP for operations and tools for data analysis and reporting (Word, Excel, Visio, JMP, Minitab, etc.).
• Experience executing or overseeing supplier qualification activities for FDA/EMA-regulated aseptic manufacturing facilities.
• Proven experience in auditing internal and external sites/functions.
• Certified Quality Auditor or equivalent certification preferred.