Quality Specialist II

Description:
The Position
We thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

• Oversee and execute all required quality activities during the lifecycle of a service provider and/or direct material, including but not limited to:
• Negotiation and maintenance of Quality Agreements
• Negotiation and maintenance of Supplier Quality Evaluations
• Monitoring cGMP compliance, identifying and mitigating quality risks
• Supporting audits, ensuring audit responsiveness and CAPA implementation
• Work with suppliers to effectively meet company requirements
• Approve as Quality Assurance on supplier documents
• Change management – assess and implement
• Maintain the Global Approved Supplier List
• Change management – assess, approve, and implement
• Discrepancy/investigation – assess, approve, and manage

• B.A. or B.S. degree in life sciences
• Minimum of 6 years’ experience in the pharmaceutical industry
• Minimum of 2 years’ experience in a GMP Quality Assurance role
• Demonstrated ability to apply cGMP concepts and requirements to evaluate using sound judgment and decision making (Hard)
• Strong problem-solving skills using critical thinking, identifying risk-based resolutions (Soft)
• Excellent verbal and written communication skills; fluency in oral and written English is a must (Soft)
• Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives (Soft)