Teva Senior Manager Quality Control - West Chester PA On-site 

United States, Pennsylvania, East Bradford Township 

988863180

As a Senior Manager of Quality Control you will manage a quality control analytical group as well as work with matrix teams to provide testing support in biopharmaceutical development, focusing on release and stability testing for biological products and the corresponding lab investigations. You will also manage analytical method validation and transfer activities, assess, improve and maintain local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, etc.), and supervise resources and assets that could include a small team and multiple simultaneous product specific projects.

• 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.
• Developing staff, creating opportunities for technical and personal development of the team and supporting the growth of the next generation of Teva leaders are also essential aspects of this position.

• Manage Quality Control laboratory operations, support and manage release and stability testing of biologic products.
• Manage method transfer and validation activities for separations chemistry (SEC, CGE, iclEF) and other analytical techniques (protein concentration, residual DNA).
• Manage verification of compendia! procedures.
• Perform raw data and LIMS review and approval.
• Manage method feasibility and coordinate interaction with Analytical Development to ensure procedures are appropriate for QC use.
• Coordinate life cycle management: Initiate, prepare, evaluate and recommend actions regarding proposals for improved analytical methods.
• Identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols and reports.
• Support QC lab investigations, compliance and audits. Contribute to inspection readiness through performing gap assessments of corporate standards and continuous improvement of data integrity within QC operations.
• Assist with raw material, in-process and potency testing functions as needed.
• Review and approve metrology and IT qualification protocols and reports for new and existing laboratory equipment.
• Develop staff to ensure their skill match roles, improving productivity and efficiency of the department operation.
• Participate in budget planning including capital equipment budgets. (Propose capital purchases and execute purchases.)
• Participate in technical and cross functional team meetings as the analytical testing lead.

Required:

• Bachelor's degree in Analytical Chemistry, Biochemistry or Biology.
• 10 years of experience in Analytical Chemistry within the pharmaceutical industry.
• 3 years of people management experience.

Preferred:

• PhD with 2 years of experience in Analytical Chemistry within the pharmaceutical industry.

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