Senior Manager, Quality Assurance - Validation, Automation and Engineering

Teva Pharmaceuticals • West Chester, IA

25d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• Management/ leadership experience preferred
• Experience in software systems such as Trackwise, Veeva and CMMS preferred

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior