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This position is responsible for providing support for the quality management systems (QMS), including documentation management, Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification. The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders. This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control.
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.
Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.
Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.
Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.
Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
Responsible for participating in partner, internal and regulatory inspections and audits as needed.
Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.
Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
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Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
Responsible for completing all 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), Standard Operating Procedures (SOP).
Responsible for performing additional related duties as assigned.
Bachelor’s Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.
Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.
Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.
Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)
Project management and advanced presentation skills preferred
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.
Frequent exposure to low to moderate noise levels.
Occasional exposure to moving mechanical parts or equipment.
May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, hearing protection, gloves, etc.).
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.
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 disabilityassistance@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.
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.
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Full-time
Senior · 7+ years experience
Onsite
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