Mgr Quality Control

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We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

This position is responsible for coordinating and managing all work associated with the various phases of the commercial production schedule at an Oral Solid Dose (OSD) Biologic Vaccine manufacturing site. The role includes planning and scheduling of raw materials, finished products, method transfer, and special projects into the Quality Control (QC) testing sections as applicable. Additionally, this position will conduct and document laboratory investigations and execute projects.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for management and development of direct and indirect reports.
• Responsible for overseeing projects carried out by senior direct reports.
• Responsible for assisting and coordinating the initial and on‑going training of analysts and technicians with regard to safety, regulatory and cGMP issues associated with working in the QC Laboratory.
• Responsible for prioritizing and coordinating testing of raw material, in‑process, bulk product, packaged finished product, stability samples, micro samples, and/or water samples for analysts, as needed to support manufacturing. Assist in the checking/auditing of raw data and various logs generated by analysts.
• Responsible for liaising between QC functional groups (Finished Product, Raw Materials, Sampling, etc) and internal and external partners to set priorities and schedules to meet timelines.
• Responsible for generating a rolling daily/weekly Master Planning Schedule for Quality Control Lab based off the priority of Operations.
• Responsible for compiling QC Metrics (internal and corporate) and communicating within and above site as required.
• Responsible for conducting or coordinating the creation of Incident, Deviation and Out of Specification Investigation and Out of Trend Investigation reports.
• Responsible for assisting in maintenance of equipment and computerized systems as needed. This includes overseeing maintenance, qualification and GMP status of laboratory instruments needed for sample analysis or other analytical work.
• Responsible for performing complex revisions to Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for coordinating and designing activities associated with the stability program including sample management activities and data analyses and performing statistical analyses.
• Responsible for project management activities for certain projects related to capacity, efficiency, and utilization.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/

Experience:

• Bachelor’s degree in chemistry or related scientific discipline or equivalent with a minimum of 5 years relevant progressive experience in a Quality Control laboratory environment.
• Minimum of 2 years of management experience in an environment supporting a production operation.
• Requires experience with an in‑depth knowledge of cGMP and other applicable industry regulatory…