Compliance Specialist III
Salt Lake City, United States, Utah, 0000
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 will be responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The position is responsible for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations.
How You’ll Spend Your Day
- Prepare and support communication of site quality system status through management review forums.
- Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance.
- Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations.
- Coordinate and manage external audits/inspections, including timely responses and CAPA tracking.
- Oversee Inspection Readiness program to maintain site preparedness.
- Collaborate with Site Operations and Quality Management to resolve compliance issues promptly.
- Conduct Knowledge Management activities, including regulatory review and gap assessments.
- Support investigation reviews and corrective action plans, ensuring proper documentation and notification.
- Manage vendor/supplier qualification and related compliance activities.
- Ensure periodic document reviews and gap assessments for department and site compliance.
- Own and update procedures for assigned responsibilities.
- Lead special cross-functional projects and present findings to senior management.
- Complete required training and maintain compliance with all assignments.
- Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records.
- 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.
- Bachelor’s Degree, preferably in a scientific or engineering discipline, with a minimum of 7 years relevant experience required\
- Experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems required
- Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment required
PHYSICAL REQUIREMENTS:
Constant:
- Sitting for extended periods of time at workstation or mobile equipment.
- Using fingers to perform activities such as picking, pinching or typing.
Frequent:
- Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
- Walking to move short distances quickly and frequently.
Occasional:
- Twisting/Reaching – turning at waist and extending hands and/or arms in any direction.
- Pushing and/or Pulling – using upper extremities to exert force.
- Grasping – applying pressure to an object with the fingers and palm.
- 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.).
Also Good to Have
- Prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems in the pharmaceutical industry.
- Experience providing support for regulatory agency inspections preferred.
- Experience with writing and negotiating Quality Technical Agreements preferred.
- Experience in a pharmaceutical manufacturing environment preferred.
- Experience with internal/external auditing is preferred.
- ASQ CQE/CQA Certification (or equivalent) is preferred.
Skills/Knowledge/Abilities:
- Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, TrackWise, Veeva, and Qdocs.
- Ability to manage multiple priorities and reporting requirements.
- Ability to motivate and influence others with and/or without direct supervisory authority.
- Ability to communicate effectively with excellent written and oral communication skills.
- Ability to interact positively and collaborate with co-workers, management and internal/external partners.
- Detail oriented with ability to analyze information, develop possible solutions, create metrics and articulate the link to business needs/objectives.
- Project management and advanced presentation skills.
- Self-directed with ability to organize and prioritize work.
Problem Solving:
- Proactively works on problems of a moderate to 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 recommend 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 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.
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.
