Quality Assurance Manager/Team Leader

What's it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles.

We're a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. And we're excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.

We are currently searching for a Quality Assurance Manager to join our team.

Summary

The QA Manager is accountable for ensuring cGMP compliance within the site's initial mAbs Bio-packaging Operations and future Biological and Pharmaceutical 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 assistance with area batch record reviews and applicable 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 mAbs/ABI/BPM/Pharmaceutical manufacturing, and all Bio-packaging Operations within Zoetis Atlanta Operations.

This position will initially support the Atlanta Project design, installation, qualification, validation, and registration of mAbs Bio-packaging Operations, and will ultimately lead a team of compliance specialists and OTE colleagues, supporting all future site manufacturing and packaging activities.

This individual will assume a leadership role in Quality Operations, working with internal and external groups, independently prioritizing areas of quality concern and addressing with limited manager intervention. The role requires an 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; and work with a team to meet site objectives.

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 leadership and support for product process validation activities for mAbs/ABI/BPM/Pharmaceutical and Bio-packaging Operations.
• Ensure cGMP compliance within the Biological and Pharmaceutical Operations systems.
• Interpret and enforce FDA, USDA, EMA, 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.
• Oversee internal audits.
• Participate in change management activities.
• Assist in the review and assessment of Zoetis Quality Standards (ZQS).
• Collect and communication of site and department metrics.
• Maintain department Standard Operating Procedures (SOPs).
• Other responsibilities as assigned.

Management Oversight

• Regulatory/GMP Inspections
• Manufacturing Support
• Batch Record Review
• Incoming Packaging Material Inspection and Intermediate Product Release
• Deviation investigations
• Change Management Activities

Education and Experience

• B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience.
• 3+ years of supervisory experience 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 biologicals and/or pharmaceutical manufacturing and packaging
• Demonstrated knowledge of the Deviation (Trackwise), Change Control (Trackwise), ValGenesis, 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, process deviation investigations, and change control.

Physical Position Requirements

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

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.