Sr. Quality Assurance Specialist

Vendor Qualification Program

Maintain and manage a risk-based model for qualification and quality oversight of GCLP, GCP, GLP vendors (and GMP vendors, as needed).

Ensure the conduct of regular vendor assessments or audits of GCLP, GCP, GLP (and GMP vendors, as needed) to evaluate regulatory compliance, performance, and improvement opportunities (via questionnaire and/or audit), involving GCP/GLP/GCLP QA and SMEs, as appropriate.

Serve as primary interface with GCP/GLP/GCLP QA and related functional area staff on topics relevant to vendor qualification.

Identify, track status, and schedule audits and assessments of GCLP, GCP, GLP (and GMP vendors, as needed). vendors

Advance the Vendor Qualification program by identifying opportunities and implementing risk-appropriate enhancements to program infrastructure.

Support functional area staff to resolve vendor observations and quality issues, including risk/impact assessment and CAPA development, execution, and effectiveness checks.

Maintain and evolve mechanisms that ensure awareness and application of Vendor Qualification QMS requirements.

Contribute to the development, implementation, and maintenance of SOPs, Policies, and Quality Agreements.

Support coordination and management of regulatory agency inspections and parent company audits, as appropriate.

Job Responsibilities

Perform other duties as assigned by Quality Assurance Management.

Minimum Requirements

• Bachelor’s degree in science, health care, business, or other relevant field and 5+ years of relevant industry experience
• Knowledge of industry best practices and regulatory requirements, including, Good Clinical Laboratory Practices (GCLP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP)
• Experience in vendor qualification or vendor management
• Strong collaborative skills; ability to work cross-functionally in a matrixed environment
• Ability to proactively and diplomatically identify and resolve quality issues/discrepancies
• Ability to prioritize, organize, work independently, and manage multiple projects/tasks simultaneously
• Analytical mindset with strong attention to detail
• Excellent interpersonal, verbal, and written communication skills
• Proficiency in MS Word, Excel, PowerPoint, and other applications

Preferred Education, Experience And Skills

• Laboratory, clinical research, and/or Quality Assurance (or related) experience
• Audit experience, including ASQ certification for auditing (CQA) or similar
• Knowledge of Good Manufacturing Practices (GMP)