Quality Systems Manager

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.

Our Team, Your Impact

This position is responsible leading the team that supports the Quality Management Systems (QMS).  This position facilitates programs for Change Management, Documentation, Validation and Qualification, Continuous Improvement, and all other elements of Quality Systems Management.  This position directs quality oversight for annual product review, change control, documentation management, validation and qualification, new product launch introduction, and continuous improvement / operational excellence projects.

How You’ll Spend Your Day

• Responsible for management and development of direct and indirect reports.
• Responsible for directing comprehensive analysis of and on time completion for Annual Product Reviews
• Responsible for oversight of the change management program to assure cross-functional engagement, thorough risk and impact assessment, as well as tracking, implementation and effectiveness of the changes.
• Responsible for managing quality review and approval of all qualification and validation documents related but not limited to, master plans, facility, equipment, process, cleaning, computer system, combination products, as well as the associated data integrity elements
• Responsible for designing and directing Continuous Improvement projects and engagement of cross functional teams for objectives, timelines, and deliverables.
• Responsible for collaborating with appropriate departments to complete gap assessments against corporate policies and resolve both technical and compliance issues related to the QMS elements
• Responsible for ensuring the QMS supports efficient, uninterrupted operation of the facility in accordance with requirements such as FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Responsible for directing the Document Management teams involved in generation, modification, review and approval of documents including but not limited to electric and paper based systems for procedures, production records, test methods, specifications, protocols and reports.
• Responsible for tracking, trending and reporting of Quality Metrics for site, regional and global review as required by procedure, corporate policy and related regulations
• Responsible for authoring, reviewing, and/or approving standard operating procedures, protocols, risk assessments and other quality records, as needed.

• Responsible for participating in partner and internal audits, as well as regulatory body inspections.
• Responsible for completing 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), Work Instructions (WI) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Your Skills and Experience

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 required
• Minimum of 5 years relevant experience required
• Minimum 2 years of previous supervisory or other relevant leadership experience.

 

• Requires experience in leading meetings, small and large groups.
• Experience with standard operating procedure development and implementation and inspection management, pre-approval inspections.
• Experience in negotiating agreements, terms and conditions.

 

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, LIMS, and Trackwise.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.

• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision making.

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