Sr Quality Systems Engineer

We Are Teva

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.

Location:

SLC EAST

577 S. Chipeta Way

Salt Lake City, UT 84108

This position is responsible for providing support for the quality management systems (QMS), including documentation management, Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification. The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders.

This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control.

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.

• Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.
• Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.
• Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.
• Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Responsible for participating in partner, internal and regulatory inspections and audits as needed.
• Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.
• Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
• Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
• 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), Standard Operating Procedures (SOP).
• 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 discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.
• Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.
• Prefer direct…