Quality Assurance Compliance Specialist

Duties:

• Lead qualification of new vendors and materials for the Hopewell site in accordance with established procedures.
• Maintain, update, and ensure accuracy of the site Approved Vendor List.
• Track, monitor, and complete periodic vendor reassessments to ensure ongoing compliance.
• Manage periodic reassessment schedules, documentation, follow-ups, and completion tracking to support supplier lifecycle oversight and continued vendor approval.
• Ensure required BSE/TSE evaluations are obtained for all materials used in manufacturing.
• Monitor supplier change notifications and initiate required site documentation as needed.
• Initiate, own, and support change controls associated with supplier changes, vendor qualification, and material qualification.
• Assist business users with creating and routing change controls required for vendor and material qualification.
• Escalate supplier changes as appropriate based on business impact and procedural requirements.
• Partner with Internal Supply Quality, External Supply Quality, Legal, and vendors to generate and route Quality Assurance Agreements for approval.
• Work with Global Quality Compliance to request vendor audits when qualifying vendors.
• Collaborate with External Supply Quality to qualify and reassess shared vendors across sites.
• Provide critical support for pre-approval inspection readiness, including FDA inspection preparation activities.
• Ensure vendor management, change management, and material qualification processes are inspection ready.
• Participate in inspection or audit backroom activities as required.
• Review and improve vendor management and qualification processes to support inspection readiness.
• Support day-to-day business needs related to vendor quality compliance.

Skills:

• Experience in Quality Assurance, Quality Compliance, Vendor Quality, Supplier Quality, or a related regulated pharmaceutical or manufacturing environment.
• Knowledge of vendor qualification, material qualification, supplier change management, quality agreements, and change control processes.
• Familiarity with inspection readiness activities and regulatory inspection support.
• Strong cross-functional collaboration, documentation, organization, and communication skills.
• Ability to manage multiple priorities and support business needs in a fast-paced regulated environment.

Education:

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline required and two years experience.
• Equivalent combination of education and relevant experience in a regulated pharmaceutical, biotechnology, or manufacturing environment may be considered.