Senior Manager, Quality Assurance - Validation, Automation and Engineering

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

Position Summary: The Senior Manager, Quality Assurance plays a critical leadership role at the West Chester Biologics Manufacturing Facility (BMF), a state-of-the-art site dedicated to delivering high-quality, life changing biologic medicines to patients. This role provides proactive quality oversight and partnership across validation, automation, engineering, and SDLC activities, ensuring GMP-compliant commissioning, qualification, and validation of manufacturing, laboratory, utility, and computerized systems. The Senior Manager drives excellence by approving QMS documentation, change controls, deviations, CAPAs, and quality risk assessments, while leading inspection readiness, CSV, and data integrity initiatives. Serving as a trusted SME, the role supports continuous improvement, training, and data review, leveraging systems such as Veeva QMS, Blue Mountain CMMS, and TevaDoc EDMS to enable compliant, agile, and patient focused operations at the BMF.

 

Responsibilities include, but are not limited to:
•    Provide quality oversight for the commissioning, qualification, and validation of GMP systems, including: manufacturing equipment, facilities equipment, utilities automation, process automation, PLC/SCADA, lab systems, analytical instrumentation, and business information 
•    Support the preparation, review, and approval of QMS documentation including: policies, SOPs, work instructions, forms, and training
•    Provide quality oversight of the Computerized Maintenance Management system
•    Oversight, review, and approval of change controls, deviations, LIRs, CAPAs, and effectiveness checks
•    Quality risk management assessments addressing patient safety, product quality, and data integrity
•    Author and/or support gap assessments of local SOPs to corporate standards as an SME 
•    Lead and/or support GMP compliance and inspection readiness initiatives related to CSV and data integrity
•    Support regulatory agency filings and inspections
•    Ensure activities are performed/completed using current Good Manufacturing Practices
•    Lead continuous improvement projects as applicable
•    Develop and/or deliver training programs as required
•    Review manufacturing data and supportive data for equipment and utilities
•    Support site efforts to ensure compliance with Teva Policies and Standards, regulatory requirements, and GMP guidelines
•    Use of Veeva, Blue Mountain CMMS, TevaDoc, and TevaLMS to execute QA activities as applicable

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. Higher education preferred.
• A minimum of 8 years of Quality Assurance, Validation or Engineering experience in a GMP regulated environment?

Skills/Knowledge/Abilities:

• Expert knowledge of Computerized Systems including Sysem Development Lifecycle in a biopharmaceutical facilities/utilities, laboratory, packaging, manufacturing and warehouse environment required
• Expert knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP, Health Canada regulations, policies and guidelines) required
• Management/ leadership experience preferred
• Experience in software systems such as Trackwise, Veeva and CMMS preferred
• Detail oriented with strong communication and organizational skills
• Team player, able to work collaboratively with all levels of QA, manufacturing, validation, automation and engineering personnel

How We’ll Take Care of You

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.  

 

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.   

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 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.