Quality Assurance Manager/Team Leader - mAbs/B2 Operations

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. We manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow.

Include: Great Health Benefits from day 1! 4 weeks accrued paid vacation and 13 paid holidays 401(k) match with company profit sharing Tuition reimbursement Student Loan Repayment Program   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.

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