Senior Supplier Quality Lead

Role Summary

The Senior Supplier Quality Lead will be assigned supplier audits as well as internal audits and oversee the Raw Materials release and inspection program under support of the Supervisor, Supplier Quality including: logistics and administration needs for 3rd party laboratory confirmation testing of raw Material quality attributes, the incoming Raw Material inspection and release process and ensuring on time delivery of critical Raw Materials for commercial HAV manufacturing.

Responsibilities

• Oversee and perform the Raw Material testing program via third-party testing laboratories and contract manufacturers
• Oversee and perform the Raw Material release program via the visual inspection process for raw materials and components received for commercial manufacturing
• Review and approval of OOS and nonconformance investigations for third-party laboratories
• Review and approval of raw material release documentation including receipt paperwork, supplier certificate of analysis, and third-party testing results against internal specifications, as applicable
• Review and approve SOPs, protocols, specifications, and reports associated with raw material QC programs / procedures, as assigned
• Execute commercial readiness projects and continuous improvement initiatives in preparedness for commercial manufacturing
• Oversee Raw Materials staff via dotted line reporting
• Create and maintain Raw Material testing schedules and metrics to ensure programs maintain a state of control and continuous material supply is met
• Act as a subject matter expert (SME) and initial point of escalation for Raw Materials team members
• Perform troubleshooting of processes and systems as they arise, guide team members in general troubleshooting, as applicable
• Executes other QA/QC responsibilities, as assigned
• Provide support for regulatory preparations and inspections
• Independently completes all aspects of supplier audits and internal audits, including, but not limited to, scheduling, documentation preparation, SME coordination, hosting, follow-up responses, and audit closure
• Partners with area leaders and subject matter experts for audit activities
• Provides audit and inspection training as needed
• Other duties, as assigned

Qualifications

• High School or GED required, Bachelor‚Äôs Degree, preferred
• 5-7 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field, required
• Minimum 4 years of experience in Raw Material programs, required
• Prior experience supporting regulatory inspections a plus
• Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry
• Strong understanding of QC Raw Material testing requirements for biological products and application for in-house and outsourced laboratories
• Cross-functional communication and third-party vendor communication is a critical aspect of this position
• General understanding of nature and application of U.S. FDA and European regulations with respect to aseptic processing, biologics manufacturing, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, and 1271; and relevant European Directives (2004/23/EC, 2006/17/EC, 2006/86/EC and 2012/39/EU)
• Understanding of cGMP compliance in the biotech/bioprocessing manufacturing environment
• Strong understanding of root cause analysis; change control requirements; Deviation/CAPA and other fundamental elements of Quality Systems
• Position may require working holidays, weekends, and over-time
• May be required to regularly sit; stand for prolonged periods of time
• May spend time in a manufacturing operations environment and will be required to meet applicable gowning and personal protective equipment guidelines, as applicable

Skills

• Quality Assurance
• Raw Materials Testing and Release
• Audit Management
• Regulatory Compliance (FDA, EU)
• CAPA / Root Cause Analysis
• Supplier and Vendor Management

Education

• High School or GED required; Bachelor‚Äôs Degree preferred

Additional Requirements

• Position may require working holidays, weekends, and overtime
• May spend time in a manufacturing environment and must adhere to gowning and PPE guidelines