Senior Manager, Laboratory Operations Support

Teva Pharmaceuticals•West Chester, IA

18d

About The Position

This position has the demonstrated knowledge, experience and skills necessary to manage the Quality Control Laboratory Operations and Stability programs with a focus on business/technical ownership of GxP-compliant laboratory equipment and computerized systems, development, improvement and execution of the stability program of clinical product(s) as well as supporting the transition of the program to Teva Global Operations upon product commercialization, and oversight of the QC sample management program (e.g. release, stability, in-process, reference standards, assay controls, etc.). Assessing, improving, and maintaining local, regional, and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position. The position requires demonstrated application of standard principles, theories, and techniques to solve specific problems in a productive manner and the ability to manage multiple projects.

Requirements

Minimum BS degree in life sciences
5-7+ years’ experience in life sciences/biologics drug development in the pharmaceutical industry
2+ years’ of supervisory experience
Knowledge of LIMS programming
Working knowledge in SDLC

Responsibilities

Maintain up to date knowledge of government regulations (e.g., FDA, EMA, MHRA, OSHA, DEA, etc.), industry standards (e.g., WHO, ICH guidance) and Teva policies and procedures.
Provide oversight of and/or manage computerized systems utilized in QC testing (e.g. LIMS, EMPOWER) as well as the network or standalone instrument systems used in the execution of testing by ensuring the relevant functionality of each system or instrument is compliant with the appropriate IT, Business and Quality requirements of the Teva system development lifecycle (SDLC) process from initiation through retirement (including modernization and continuous improvement efforts).
Provide oversight of and/or manage stability studies, including the establishment of the protocols, pulling of samples, data review and trending, shelf-life assessments (i.e. expiry/retest periods), processing of temperature excursion assessments, and serving as the QC SME and designated representative on the Stability Review Committee (SRC).
Provide oversight of and/or manage the QC sample management process with focus on chain of custody, inventory management (i.e., forecasting, maintenance of the associated CTUs, internal/external sample transfer) of release, in-process, stability, reference standard, and assay control materials.
Provide oversight and support for general QC compliance activities including but not limited to: Management and implementation (i.e., author/revise/approve) of SOPs, work instructions, standard practices, protocols, and reports.
Author, review and/or approve internal and external laboratory investigations as needed.
Author, review, or supply data for including in regulatory filings (i.e., INDs, BLA, MAA) and their associated regulatory body information requests.
Serve as QC management SME in an advisory capacity for employee data integrity, general GMP compliance, and technical skills as required.
Follow and ensure employee compliance to OSHA and Teva Environmental Health and Safety policies and procedures as an active contribution to the maintenance of a clean, safe working environment in the QC functional areas.
Develop staff by ensuring their skills and motivations suit their roles and responsibilities, as well as providing appropriate growth opportunities to maintain/increase expertise in Quality Control work activities which will improve productivity and efficiency of the department operations.
Participate in budget planning including capital and annual operations by proposing and executing purchases.
Other projects and duties as required/assigned.