Quality Assurance Person in Plant - Drug Product External Manufacturing

Responsibilities

This role is responsible for providing daily quality oversight at the Contract Manufacturers (CM) site. This role is located in person on site at the CM site the majority of the time. Additional responsibilities include providing assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, and other duties associated with daily Contract Manufacturers (CM) activities.

QA Person in Plant may be also responsible for final disposition of manufactured and/or packaged drug product batches. This role serves as DPEM QA primary contact to the CM for initial escalation and works with the JPT to ensure timely response for requests for information. They also ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

Important note: Location is at the CM manufacturing site – Cincinnati, Ohio.

Key Objectives/Deliverables:

QA Person in Plant should understand the process and equipment for their product scope, including:

• Understanding the science behind the process and equipment so that compliance-based decisions ensure ongoing effective and efficient processes.
• Knowing how upstream/ downstream processing is affected by their process steps.
• Knowing the Operational Control Strategy (OCS) and failure modes of the process.
• Knowing the historical deviations/gaps, trends, and audit history of the process.

QA Person in Plant should provide support to the CM daily operations by:

• Levelling, reviewing, and approving of event investigations and changes.
• Ensuring implementation and effectiveness of corrective and preventative actions.
• Reviewing that practice matches procedure.
• Ensuring CM's quality systems are compliant with applicable GMPs, Lilly quality standards and any additional local market requirement.
• Contribute to Quality culture efforts at both DPEM and CM.
• Spend time in all unit operations, including the lab.
• Provide primary oversight and guidance for minor investigations and change controls (initial notification and consult).
• Support onsite resolution of product related issues.
• Ensure compliance to data integrity (i.e. perform audit trail reviews).
• Perform trouble shooting for in process issues and escalate as needed.
• Review and provide approval for CM procedure changes.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Participate on Joint Process Teams (JPT).
• Review, enter, or SPV analytical data and escalate as needed.
• Ensure batches are identified and appropriately sampled for annual stability requirements.
• Provide on-site support for GQAAC audits and Regulatory inspections.
• Review and approve complaint investigations.
• Consult on Master batch record updates; provide input based on observations and interactions on the floor.
• Metrics tracking.
• Assist in gathering data to complete the CMs Site Compliance Reports (SCR); provide review as needed.
• Perform internal notification of quality issues where needed.
• Serving as a liaison between the CM and JPT.
• Ensuring that materials and products manufactured at CMs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market.
• Participate in CM performance reviews (Ex IOPs, supply management …etc).
• Track and monitor quality metrics for trends at the CMs.

Support batch release activities by:

• Complete batch record and media fill reviews (parenteral), reporting any issues.
• Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
• Originate and investigate deviations associated with batch records.
• Work with Lilly support groups to resolve product related issues.
• Create Certificates of Analysis or other similar documentation for internal and external customers as needed.
• Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product).
• Provide support for Notification to Management data gathering.
• Provide input for metrics reports to management.
• Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers.

Relationships:

• Develop and maintain strong working relationships with CM primary DPEM contacts, QA/QC personnel and shop floor personnel.
• Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations.
• Assist QA Primary loop role with providing potential topics for GQAAC audit of the CM.
• Assist CMs on the preparation of any audit from Lilly (GQAAC) or any external agency inspection that impact Lilly products.
• Follow up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the CMs is taking appropriate actions in the due time.

Continuous Improvement:

• Support continuous improvement initiatives at the CM (i.e. identify vulnerabilities and inefficiencies of the process and promote improvement projects.
• Ensure quality improvements are managed through the GMP plan process. Ensure evidence of completion and completes in a timely manner.

Basic Qualifications:

• Bachelor´s Degree in Pharmacy, Chemistry, Engineering, Biological Science or related Life Science or equivalent experience.
• Minimum 3-5 years of experience supporting quality functions, preferably within a parenteral manufacturing site.

Additional Skills/ Preferences:

• Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.
• Demonstrated ability to work independently.
• A thorough understanding of cGMPs and Global Quality Standards.
• Strong written and communication skills, especially attention to detail in written procedures and protocol development.
• High learning agility.
• Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
• Ability to organize, prioritize, multi-task and influence others.
• Strong decision making and problem-solving skills.
• Willingness to learn new technologies.
• Capability to work in a virtual and complex environment.
• Willingness to travel.
• Appreciation for cultural diversity.
• Regulatory related experience.
• Established technical, quality, and internal networks.
• Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
• Previous experience supporting batch release for parenteral and/or packaging products may be preferred.

Additional Information:

• Shift is days, but schedule flexibility and off hours may be necessary to support operations.
• Location is at the CM manufacturing site – Cincinnati, Ohio.
• Some travel (<10%) is required primarily to Indianapolis, Indiana.
• This role requires on-site presence at the contract manufacturer (located in Cincinnati, OH), a minimum of 3 days per week. In order to fulfill this on-site commitment, employees are expected to travel (by car) 3 times/week to the site. If desired, relocation support is available for those residing 50 miles outside Cincinnati.