Mgr Quality Function

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Salt Lake City, United States, Utah, 84044

Job

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 provides direct supervision of the site compliance team to effectively conduct internal audits, supplier qualification, site inspection readiness and knowledge management activities. This position also provides compliance oversight, communication and required documentation to third party and global Teva partners.

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 the daily management and development of direct reports.
• Responsible for collaborating with Site Operations and Quality Management to manage compliance issues and ensure timely resolution while meeting internal and Partner requirements.
• Responsible for facilitating, presenting and communicating status of the overall structure of site quality systems via management review forums, such as Site Quality Council.
• Responsible for managing and executing against internal audit programs to periodically audit procedures, records and systems to ensure compliance with relevant national and international regulatory agencies and guidelines.
• Responsible for providing effective processes and communications to prepare for, manage, and provide follow-up for regulatory and partner inspections/PAI/audits, including timely responses and CAPA commitments tracked to completion.
• Responsible for collaborating with relevant stakeholders to define and maintain a supplier evaluation, qualification and approval system that meets regulatory and commercial operation requirements.
• Responsible for working with partners to manage updates to Quality Technical Agreements (QTA) and communicate details to site management to assure adherence to the individual details of the QTA’s.
• Responsible for maintain appropriate licensing of the site with the regulatory bodies where products are marketed.
• Responsible for supporting the quality unit with review of investigations, corrective action plans, notification to management and field action documentation for compliance requirements and clarity in documentation.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• 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 (cGMP’s), 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, preferably in a scientific or engineering discipline, or equivalent education/experience.
• Minimum 5 years of relevant progressive experience in Quality, Operations or QC Lab including at least 4 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry.
• Minimum 3 years ofprevioussupervisory or other relevant leadership experience.
• Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Working knowledge of FDA, EMA, DEA,EPAand other regulatory requirements for a research and…