QA Person in Plant - Drug Product External Manufacturing (Virginia)

Role Summary

QA Person in Plant - Drug Product External Manufacturing (Virginia) role focusing on leading cross-functional teams to ensure manufactured and packaged drug products meet specifications, cGMP, and regulatory requirements. Provides guidance on deviation investigations, change controls, and procedure revisions, and may be responsible for final disposition of batches. Serves as DPEM QA for initial escalation and collaborates with Lilly and Contract Manufacturer representatives within the Joint Process Team.

Responsibilities

• Lead a cross-functional team of Lilly representatives; provide guidance on deviation investigations, change control proposals, and procedure/master formula revisions.
• Possibly be responsible for final disposition of manufactured and/or packaged drug product batches.
• Serve as Drug Product External Manufacturing (DPEM) QA for initial escalation; collaborate with Lilly personnel and Contract Manufacturer representatives within the Joint Process Team (JPT) to ensure timely information responses.
• Ensure batches meet specifications and are manufactured/packaged per validated processes; ensure compliance with cGMP and regulatory requirements.
• Understand process and equipment, including upstream/downstream interactions, Operational Control Strategy, failure modes, and historical deviations/trends.
• Support daily operations: review and approve event investigations and changes; ensure effectiveness of CAPAs; verify practices align with procedures; ensure quality systems comply with GMPs and local requirements.
• Contribute to Quality culture within DPEM and JPT; spend time in all unit operations, including the lab.
• Provide oversight for minor investigations and change controls; support onsite resolution of product-related issues; ensure data integrity through audit trail reviews.
• Review and approve JPT procedure changes; write protocols for non-routine testing or validation; participate in JPT activities; review SPV/analytical data and escalate as needed.
• Identify batches for annual stability sampling; support on-site GQAAC audits and regulatory inspections; review and approve complaint investigations.
• Consult on Master Batch Record updates; contribute to metrics tracking and Site Compliance Reports; perform internal quality issue notifications; ensure compliance of released materials/products with MA requirements and GMPs.
• Participate in JPT performance reviews; monitor quality metrics for trends; provide on-site support for audits and inspections.
• Assist in data gathering for management and provide input for metrics and release documentation.

Qualifications

• Bachelor's Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science, or equivalent experience.
• Minimum 3‚Äì5 years of experience supporting quality functions within a parenteral manufacturing site.

Skills

• Sterility experience
• Ability to represent Lilly's mission, policies, and practices professionally and to influence JPTs
• Ability to work independently; strong written and verbal communication; attention to detail
• Thorough understanding of cGMPs and Global Quality Standards
• Strong leadership, interpersonal and teamwork skills; ability to work in cross-functional teams
• Organizational, prioritization, multi-tasking, and problem-solving abilities
• Willingness to learn new technologies; ability to work in virtual/complex environments; appreciation for cultural diversity

Education

• As listed in Qualifications

Additional Requirements

• Regulatory-related experience; experience with Lilly systems (SAP, Trackwise, Q docs, etc.)
• Willingness to travel within the United States; on-site presence required in Richmond, VA (minimum 3 days/week); relocation available