Position Summary
The QA Manager/TL is accountable for ensuring cGMP compliance within the site's B2 MAb and Biological Operations and is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives. Primary responsibilities include: product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site's compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of ABI/MAb manufacturing within Zoetis Lincoln Biological Operations. Assist with transfer of new monoclonal antibody (Mab) biological therapeutic products and ABI products into GMS. This position will lead a team of 5 compliance specialists and support all associated activities.

Taking a leadership role in the Quality Unit, working with internal and external groups, independently prioritizing areas of quality concern and addressing with limited manager intervention. Ability to organize resources and address complex quality decisions independently and efficiently. Communicate effectively and decisively with manufacturing team members as well as members of site management. Work with a team to meet

The QA Manager/TL will also interface directly with regulatory agency, customers, and internal auditors, provide support for market action activities, and will assist in the identification and communication site and department metrics.
Position Responsibilities
• Provide QA support for product process validation activities for MAb manufacturing
• Provide QA support for MAb product registrations and compliance
• Ensures cGMP compliance within the Biological Operations systems
• Interpretation and enforcement of FDA, USDA, EU, and other regulatory guidelines
• Provides guidance and support within cGMP systems for site colleagues
• Support regulatory agency, customer, and internal audits
• Review and approval of action items / commitment tracking items
• Review and approval of investigation and interim reports
• Support market action activities
• Perform internal audits (external audits as necessary)
• Batch record review, intermediate product release
• Participation in change management activities
• Assist in the review and assessment of Zoetis Quality Standards (ZQS)
• Collection and communication of site and department metrics
• Maintain department Standard Operating Procedures (SOPs)
• Other responsibilities as assigned

Education and Experience
B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. M.S. degree is preferred.

Technical Skills and Competencies Required
Minimum Qualifications:
• Risk Management
• Investigation and Problem Solving
• Demonstrated technical capabilities
• Ability to establish appropriate timelines to meet key milestones under minimal supervision
• Deep knowledge of local, federal, and international regulations
• Knowledge of human error awareness / prevention
• Organization skills
• Verbal and written communication skills (fluent in English)
• Works effectively in a team-based environment
• Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines
• Proficient in Microsoft Office applications
• Attention to detail
• Demonstrated ability to work with internal and external colleagues
• 6-sigma, lean or statistical skills
Preferred Qualifications:
• Previous experience with methods in protein purification
• Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Equipment Change Control (CCDB) database, ERP (SAP) and Laboratory Information Management (LIMS) systems.
• Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
• Previous experience with batch record review, and process deviation investigations.

Physical Position Requirements
• Lift materials up to 40lbs
• Ability to sit, stand and walk
• Some travel may be required

Full time

Regular

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