Sr. Director - QC Labs IPM

Senior Director - Qc Labs IPM

At Lilly, we unite caring with discovery to make life better for people around the world. We are looking for people who are determined to make life better for people around the world. The Senior Director - QC Labs IPM is responsible for the oversight and execution of the product testing; including chemical and / or micro tests for raw materials, in-process samples, semi-finished and finished products, physical and functional testing of drug / device combination product and visual and physical testing of packaging components. Responsible for ensuring there is an adequate quality system in place for material and product testing, including instructions and procedures to execute the testing, that testing equipment and instruments are qualified, and personnel trained. As member of site management team, they are responsible for the adequate resourcing of the quality control unit and the continuous professional development of the quality control team. This position requires the ability to multitask / prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement solutions. This role will serve as a site / plant agent to manage compliance to all cGMP, procedures, policies, and guidelines, and support development of the business plan.

Key objectives / deliverables include : maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE corporate and site goals; participating in human resource development, human resource planning, and performance management plans for direct reports; serving as a conduit for corporate communications; creating and managing site quality plan; recruiting new talent, technical and compliance consistency across plants; coordinating and managing regulatory inspections; communicating to and striving for integration of support groups outside of the plant; recruiting / retaining effective diverse staff, supervising, coaching, and aiding in development, performance management, ensuring a fair and equitable work environment; leadership role in the implementation of quality systems; influencing development of improved and streamlined quality systems; providing technical support and expertise for site and corporate on analytical topics; defining and maintaining inspection readiness activities; interacting with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility issues; networking internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure customer needs are met; networking with other sites regarding new systems development and best practices for analytical processes; developing plan for capital purchases.

Although authorized members of the quality control unit can perform the activities listed in this section, this role maintains ultimate responsibility for the following : to approve or reject, as they see fit, starting materials, packaging materials, intermediate, bulk, and finished products; to ensure that all necessary testing is carried out and the associated records evaluated; to approve specifications, sampling instructions, test methods, and other quality control procedures; to approve and monitor any contract analysts; to ensure the qualification and maintenance of their department, premises, and equipment; to ensure that the appropriate validations are done; to ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need; to ensure adequate design, effective implementation, monitoring, and maintenance of the quality management system; the authorization of written procedures and other documents, including amendments; the monitoring and control of the manufacturing environment; plant hygiene; process validation; training; the approval and monitoring of suppliers of materials; the approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities; the designation and monitoring of storage conditions for materials and products; the retention of records; the monitoring of compliance with the requirements of Good Manufacturing Practice; the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality; participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement; ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

Minimum requirements include a bachelor's of science degree in chemistry, microbiology, or related science field and 10+ years of experience in the pharmaceutical industry with previous supervisory experience.