Quality Systems Manager
Teva Pharmaceuticals
2 hours ago
On-site
Salt Lake City, UT
Operations
Responsibilities
- Lead the team supporting Quality Management Systems (QMS).
- Facilitate programs for change management, documentation, validation and qualification, continuous improvement, and other quality system elements.
- Provide quality oversight for annual product review, change control, documentation management, validation and qualification, new product launch introduction, and continuous improvement/operational excellence projects.
- Manage and develop direct and indirect reports.
- Direct comprehensive analysis and on-time completion of Annual Product Reviews.
- Oversee the change management program, including cross-functional engagement, risk/impact assessment, tracking, implementation, and effectiveness.
- Manage quality review and approval of qualification/validation documents (e.g., master plans, facility, equipment, process, cleaning, computer systems, combination products) including associated data integrity elements.
- Design and direct continuous improvement projects; engage cross-functional teams for objectives, timelines, and deliverables.
- Conduct gap assessments against corporate policies and resolve technical and compliance issues related to QMS elements.
- Ensure the QMS supports efficient, uninterrupted facility operations in accordance with applicable requirements (e.g., FDA, MHRA, EMEA, OSHA, EPA, DEA).
- Direct document management teams for generation, modification, review, and approval of procedures, production records, test methods, specifications, protocols, and reports.
- Track, trend, and report quality metrics for site/regional/global review.
- Author, review, and/or approve SOPs, protocols, risk assessments, and other quality records.
- Participate in partner/internal audits and regulatory inspections.
- Complete training requirements and maintain compliance with all assignments.
- Maintain safe/efficient work areas and perform duties in accordance with company policies, cGMPs, SOPs, work instructions, and batch record instructions.
- Perform additional related duties as assigned.
Qualifications / Required
- Bachelor’s Degree required.
- Minimum 5 years relevant experience.
- Minimum 2 years supervisory or relevant leadership experience.
- Experience leading meetings with small and large groups.
- Experience developing and implementing SOPs and managing inspections/pre-approval inspections.
- Experience negotiating agreements, terms, and conditions.
Preferred
- Direct experience manufacturing various pharmaceutical dosage forms.
- Direct experience with health authority inspections (e.g., FDA/EMA, ANVISA).
Skills / Knowledge / Abilities
- Proficiency with MS Office, LMS, EDMS, ERP, LIMS, and Trackwise.
- Ability to motivate, influence, and lead others (with or without direct supervisory authority).
- Ability to manage conflict, provide difficult feedback, and negotiate resolution.
- Ability to build and maintain collaborative relationships across teams/departments/business units.
- Sound judgment and decision-making.
- Strong written and oral communication skills.
- Ability to analyze information and create business-relevant metrics.
- Ability to drive change and manage transitions.
- Project management and advanced presentation skills.
- Risk-based decision making.
Problem Solving
- Proactively work complex scope problems requiring analysis of data and known/unknown factors.
- Seek resources to determine appropriate methods/techniques.
- Independently direct methods/procedures for problem resolution.
Benefits (explicitly listed)
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription).
- Retirement Savings: 401(k) with employer match; up to 6% and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holiday).
- Company-paid Life and Disability insurance.
- Additional benefits listed (e.g., EAP, tuition assistance, flexible spending accounts, health savings account, paid parental leave if eligible, etc.).
- Compensation may include restricted stock units and discretionary awards (details provided if offered).
Application Instructions
- Apply through Teva’s internal career site on Twist. If already working at Teva, apply via the internal career site on Twist.
- Lead the team supporting Quality Management Systems (QMS).
- Facilitate programs for change management, documentation, validation and qualification, continuous improvement, and other quality system elements.
- Provide quality oversight for annual product review, change control, documentation management, validation and qualification, new product launch introduction, and continuous improvement/operational excellence projects.
- Manage and develop direct and indirect reports.
- Direct comprehensive analysis and on-time completion of Annual Product Reviews.
- Oversee the change management program, including cross-functional engagement, risk/impact assessment, tracking, implementation, and effectiveness.
- Manage quality review and approval of qualification/validation documents (e.g., master plans, facility, equipment, process, cleaning, computer systems, combination products) including associated data integrity elements.
- Design and direct continuous improvement projects; engage cross-functional teams for objectives, timelines, and deliverables.
- Conduct gap assessments against corporate policies and resolve technical and compliance issues related to QMS elements.
- Ensure the QMS supports efficient, uninterrupted facility operations in accordance with applicable requirements (e.g., FDA, MHRA, EMEA, OSHA, EPA, DEA).
- Direct document management teams for generation, modification, review, and approval of procedures, production records, test methods, specifications, protocols, and reports.
- Track, trend, and report quality metrics for site/regional/global review.
- Author, review, and/or approve SOPs, protocols, risk assessments, and other quality records.
- Participate in partner/internal audits and regulatory inspections.
- Complete training requirements and maintain compliance with all assignments.
- Maintain safe/efficient work areas and perform duties in accordance with company policies, cGMPs, SOPs, work instructions, and batch record instructions.
- Perform additional related duties as assigned.
Qualifications / Required
- Bachelor’s Degree required.
- Minimum 5 years relevant experience.
- Minimum 2 years supervisory or relevant leadership experience.
- Experience leading meetings with small and large groups.
- Experience developing and implementing SOPs and managing inspections/pre-approval inspections.
- Experience negotiating agreements, terms, and conditions.
Preferred
- Direct experience manufacturing various pharmaceutical dosage forms.
- Direct experience with health authority inspections (e.g., FDA/EMA, ANVISA).
Skills / Knowledge / Abilities
- Proficiency with MS Office, LMS, EDMS, ERP, LIMS, and Trackwise.
- Ability to motivate, influence, and lead others (with or without direct supervisory authority).
- Ability to manage conflict, provide difficult feedback, and negotiate resolution.
- Ability to build and maintain collaborative relationships across teams/departments/business units.
- Sound judgment and decision-making.
- Strong written and oral communication skills.
- Ability to analyze information and create business-relevant metrics.
- Ability to drive change and manage transitions.
- Project management and advanced presentation skills.
- Risk-based decision making.
Problem Solving
- Proactively work complex scope problems requiring analysis of data and known/unknown factors.
- Seek resources to determine appropriate methods/techniques.
- Independently direct methods/procedures for problem resolution.
Benefits (explicitly listed)
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription).
- Retirement Savings: 401(k) with employer match; up to 6% and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holiday).
- Company-paid Life and Disability insurance.
- Additional benefits listed (e.g., EAP, tuition assistance, flexible spending accounts, health savings account, paid parental leave if eligible, etc.).
- Compensation may include restricted stock units and discretionary awards (details provided if offered).
Application Instructions
- Apply through Teva’s internal career site on Twist. If already working at Teva, apply via the internal career site on Twist.