Senior Quality Engineer, Risk Management

Senior Quality Engineer, Risk Management

As a Senior Quality Engineer, Risk Management, you will support and lead quality assurance activities for Third Party Manufacturing (TPM) plants as part of our Pharmaceutical quality assurance (PQA) function.

During routine operations, the Senior PQA Analyst is responsible for supporting the day‑to‑day Quality Assurance activities related to the TPM plants including approval of manufacturing directions to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assessment of product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. You also evaluate supplier change notifications, monitor process tracking and trending, and perform annual Product Quality Reviews.

You act as a liaison between Abb Vie regulatory areas and TPM plants for regulatory submission.

• Maintain an effective liaison and cooperative relationship with other Abb Vie areas including Quality, Regulatory, Technical, Supply Chain, and TPM sites.
• Ensure bulk drug substance and/or drug product production at TPM sites is performed per cGMP, local procedures, and Abb Vie QA operations specifications and directions.
• Ensure TPM procedures for raw material specification, product specification, test methods, supplier change notification, and shipping comply with cGMP, policies, regulatory approvals, and QTA with TPM sites.
• Review and approve manufacturing directions to the production floor.
• Support PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
• Ensure investigations of TPM plant events (process, laboratory, raw materials) are completed thoroughly and documented accurately, including product impact analyses and corrective and preventive actions.
• Perform annual Product Quality Review per Abb Vie global procedure to comply with regulatory requirements.
• Participate in Trend Review Board to monitor process tracking and trending.
• Participate in Global Change Review Board (GCRB) as TPM representative to evaluate global changes related to supplier change notifications, process, laboratory, and regulatory submissions that impact all sites.
• Generate detailed change management plans for TPM plant changes to achieve intended results; including planning, risk analysis, and implementation.

• Bachelor’s degree preferably in Engineering or Science.
• Six years of experience in pharmaceutical operations, preferably biologic manufacturing process.
• Knowledge of GMP regulations and standards affecting pharmaceutical products.
• Comprehensive knowledge of business and quality concepts.
• Strong analytical skills and attention to detail.
• Experience with change plans, exception reports, SAP, and LRMS is highly preferred.
• Proven ability to adapt communication style for a variety of modes and multicultural audiences.
• Strong interpersonal and communication skills; able to effectively communicate across all levels of the organization.

• Compensation range is the starting base pay range for this role based on the job grade at the time of posting. Individual compensation may vary based on geography, experience, and performance.
• A comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligibility to participate in short‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only – for more information, visit .

US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more: ‑accommodations.html