Quality Systems Manager
Salt Lake City, United States, Utah, 00000
We Are Teva
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.
- 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 analyze information and create metrics relevant to the business objectives.
- Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.
- Project management and advanced presentation skills required
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 results.
- Acts independently and proactively to direct method and procedure for problem resolution.
- Proficient risk based decision making
Also Good to Have
- Preferred direct experience with the manufacturing of various pharmaceutical dosage forms.
- Preferred direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)
Physical Requirements
Constant:
- Sitting for extended periods of time at work station or mobile equipment.
- Using fingers to perform activities such as picking, pinching or typing.
- Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
Frequent:
- Twisting/Reaching – turning at waist and extending hands and/or arms in any direction.
Occasional:
- Standing for extended periods of time at work station or equipment.
- Pushing and/or Pulling – using upper extremities to exert force.
- Lifting – raising from lower to upper and/or moving objects horizontally up to 25 lbs.
Visual Acuity:
- Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
WORKING ENVIRONMENT
- Exposure to low noise levels in an office environment.
- Occasional exposure to moderate to loud noise levels.
- Occasional exposure to moving mechanical parts or equipment.
- Required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).
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 holiday.
• 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.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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 AskHR@tevapharm.com 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.
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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.
