Sr Principal Associate - Drug Product External Manufacturing QA Laboratory Secondary Loop

We’re looking for people who are determined to make life better for people around the world.

Organization :

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners.

This oversight covers the process steps of selection, pre-validation / validation, ongoing operations, and termination.

Drug Product External Manufacturing Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

Key Objectives / Deliverables :

DPEM Laboratory Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to Contract Manufacturers (CMs) and other DPEM members for lab activities.

Secondary loop is responsible for improving technical capabilities, supporting operational control strategy, resolution of the most critical / complex deviations and leading complex projects.

This role provides guidance to primary loop with respect to daily CM laboratory activities and leads / participates in method transfers and method / process validations to ensure that laboratory activities conducted by CMs are executed in accordance with company quality policies and procedures and comply with current Good Manufacturing Practice (cGMP) guidelines and regulations.

Oversight of Laboratory and Stability Quality System and operations include the following :

• Subject Matter Expert and Technical Mentor for Laboratory system quality elements. Provide feedback, coaching, mentoring to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to laboratory topics.
• Improve DPEM technical capabilities by providing guidance to primary loop representatives.
• Through liaison with DPEM Management and Quality staff monitor the performance at contract manufacturers and identify concerns as relevant.

Escalate concerns in a timely manner with recommendations.

• Provide support for onsite and remote Inspections / Audits (observation and answers), before during and after inspection.
• Provide training in relation with Laboratory topics within DPEM and CMs upon request.
• Develop internal network contacts for supporting investigations, keeping aware of emerging topics in Lilly and understanding the impact on Contract Manufacturing Laboratory activities.
• Develop strategies for ensuring that Contract Manufacturers are aware of emerging laboratory trends and provide support (as needed) to implement their plans for meeting the standards.
• Participate in the creation and review of local procedures related to laboratory quality activities.
• Review new and revised standards related to the laboratory
• Complete related assessments and determine impact on DPEM processes and procedures. Work with DPEM management and Quality Systems owners to develop and create appropriate action plan to ensure alignment with required standards.
• Review, maintain and improve DPEM Standard Operating Procedures (SOPs) related to laboratory (Reference standards, Pharmacopeia changes, Analytical investigations, and Laboratory accreditation) and Stability (Stability management).
• Track and monitor laboratory metrics for trend for CMs / products included in the same platform (Dry and Parenteral).
• Perform annual stability report including global standard changes and assessment and prepare periodic updates of the stability plan.

Contract Manufacturing support (as required) :

• Provide guidance and support for deviations, change controls, CAPA identification, technical report writing, as needed.
• Review / approve major deviations and change controls, technical reports, and any other analytical document, as needed.
• Lead critical / complex deviations (as required).
• Provide laboratory accreditation support. Perform the annual laboratory accreditation plan to ensure compliance to laboratory accreditation schedule across CM and follow up of identified actions status.
• Provide oversight to DPEM stability program, including protocols, studies, metrics and routine overview of data and metrics.
• Assess capabilities of existing CMs to produce additional products, particularly with regards to laboratory topics.
• Provide support to the assessment of new laboratories / implementation of new products / CM.
• Provide support to analytical transfer activities. Review method transfer / validation protocols as required.
• Primary contact person for : Global method changes impacting external manufacturing : Coordination with related QA contact of the impacted CM to confirm impact assessment, global method and change approval where applicable and local implementation oversight.

Global compendia changes, pharmacopeia notifications and updates. Evaluation of global compendia reports, impact assessment and notification management to the QA reps for impacted CMs.

Reference standards profiles changes : Management of global notifications for profiles publications, link with CRSO for profiles delays or cancelation.

Data integrity topics and initiatives related to the laboratory.

• Provide method transfer certification support (New products, method changes requiring certification)
• Facilitates communications between QA Leads / CMs and global SMEs relating to laboratory and stability standards.
• Provide support to the laboratory performance review and Stability program monitoring in scope of Joint Process Team dashboards, huddle boards, IOPs and Steering meetings reviews.

Basic Qualifications

• Education : Bachelor’s Degree in Pharmacy, Chemistry, Biological Science or related Life Science or equivalent experience.
• Experience : Minimum 10+ Quality Control Laboratory experience in a GMP environment

Additional Skills / Preferences

• Established technical, quality, and internal networks.
• Experience with electronic data systems (Darwin / LIMs, SAP, Trackwise, QDocs).
• Previous experience supporting parenteral manufacturing operations.
• Understanding of micro / sterility testing.
• Strong Coaching / Mentoring skills.
• Knowledge of laboratory quality system, method, and equipment.
• Technical understanding of GMPs and the Global Quality Standards.
• A thorough understanding of cGMPs and Global Quality Standards.
• Strong written and communication skills, especially attention to detail.
• 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.

Additional Information

• Shift is days, but off hours may be necessary to support operations.
• Travel is possible, up to 30 %.

Lilly is an EEO / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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