Quality Engineering 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 for planning and managing the Quality Engineering and assigned investigator tasks related to deviations, laboratory investigations, complaints, maintenance/calibration and CAPA systems.

Location:

SLC - West

4710 W. Wiley Post Way

Salt Lake City, UT 84116

How You’ll Spend Your Day

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 management and development of direct and indirect reports.

*Responsible for establishing and maintaining procedures and processes for timely review and approval of deviation reports, laboratory investigations and product complaints.

*Responsible for establishing and maintaining procedures with area leaders to develop CAPA and effectiveness checks in order to resolve an event with execution of action plans.

*Responsible for periodic trend analysis data compilation and reports, along with recommendations for improvement.

*Responsible for establishing and maintaining procedures to provide oversight of maintenance and calibration activities including facilities, equipment, and critical utilities. This includes establishing processes for reviewing EAM records for GMP equipment where a batch was involved.

*Responsible for establishing and maintaining procedures in alignment with Teva Corporate requirements to develop and publish NTM reports and FDA field alerts for significant quality events.

*Responsible to manage Partner deviations, laboratory investigations and associated CAPA to ensure timely resolution meeting internal and Partner requirements.

*Responsible for acting as an SME and participating directly in internal/external 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, current Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOPs).

*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:

*Bachelors Degree in Science/Engineering or equivalent with a minimum of 5 years relevant progressive experience in the pharmaceutical or medical device industry.

*Requires experience with the handling of deviations, investigations and CAPAs.

*Requires experience in a GxP manufacturing environment with an in-depth knowledge of CGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.

*Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Learning Management Systems and statistical software preferred.

*Experience with managing partner relationships preferred.

*ASQ/CQE/CQA Certification preferred.

Also Good to Have

Skills/Knowledge/Abilities:

*Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP and other Quality systems.

*Self-directed with ability to organize and prioritize work.

*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.

*Ability to communicate effectively with excellent written and oral communication skills.

*Ability to interact positively and collaborate with co-workers, management and external partners.

*Ability to understand inter-department linkages and alignment of own department with other departments.

*Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.

*Project management and advanced presentation skills.

Problem Solving:

*Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.

*Seeks out all resources when selecting methods and techniques for obtaining problem resolutions.

*Acts independently and proactively to determine and administer methods and procedures for problem resolution.

How We’ll Take Care of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Already Working @Teva?

Make sure to apply through our internal career site on Twist-your one-stop shop for career development

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [email protected] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.