This job is archived
(Archived) Quality Assurance Leader
Job Description
Position Summary
Direct the Quality Assurance functions for the White Hall site to ensure that only products meeting high quality standards, customer expectations, and regulatory requirements are provided to our customers.
Position Responsibilities
- Oversee and manage the Quality Assurance Colleagues. Plan, initiate, and direct policies, processes, and procedures to ensure all products manufactured by White Hall meet applicable USDA and Zoetis quality standards, as well as the regulatory requirements of all destination countries.
- Manage quality assurance staff providing submission of samples for products to be tested by the Control Laboratories. Ensure processes and procedures are in place for sample submission to USDA and archival of samples to support products.
- Manage the Quality Assurance Team to ensure the processes, systems, and facilities utilized at the White Hall site are continuously operated in compliance with government regulations and Zoetis guidelines by coordinating and participating in periodic audits or inspections of the site.
- Work with Regulatory Compliance to ensure all product quality actions such as quarantine hold, stop sales, withdrawal actions, or recalls of biological products manufactured by or distributed by White Hall are performed according to regulatory requirements and Zoetis Quality Standards.
- Manage Quality Assurance in an effective manner within budget guidelines, where possible.
- Ensure consistent manufacturing and control systems are in place by overseeing the review and approval of critical Standard Operating Procedures and all biological manufacturing Batch Records.
- Monitor and identify when improvements are needed with the Quality Assurance activities.
- Work with Lincoln QO and site management to ensure proficient and knowledgeable GMP auditing and inspection staff by providing periodic training on pertinent subjects and, where applicable, provide the opportunity to achieve formal certification recognized by international authorities.
- Ensure continued regulatory compliance within Establishment 190 sites by actively participating on key teams and task forces and making appropriate recommendations when needed to assure compliance.
- Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
- When adverse trends of field complaints concerning the quality of Zoetis products are identified, work with the manager of field complaints and manufacturing to take appropriate corrective action.
- Lead GMP regulatory inspections of White Hall Operations and actively participate in other regulatory inspections, when required.
- Actively participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers.
Education and Experience
- Bachelor’s Degree with 7 years or equivalent expereince.
- A minimum of three years QA/QC Leader experience including budget and supervisory responsibilities.
- A thorough familiarity with US. Regulations (USDA) for biological products and their application.
- Excellent written and verbal communication skills.
Technical Skills and Competencies
Minimum Qualifications:
- Demonstrated ability to perform and reach targeted conclusions.
- Strong written and oral communication and ability to effectively direct a team of professionals.
- Ability to establish appropriate timelines to meet project milestones and hold colleagues accountable to timelines and activities.
- Process and detail oriented with the ability to review and/or prepare detailed structured documents.
- Ability to develop solutions to routine and complex problems.
- Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.
- Ability to communicate effectively with Team Members to facilitate completion of required Quality Assurance activities to meet all deadlines.
Preferred Qualifications:
- Demonstrated knowledge of the Deviation (QTS), Change Control (QTS), Laboratory Information Management (LIMS) and Manufacturing systems.
- Experience in validation of processes, analytical methods, equipment, cleaning, software, computer systems, etc.
- Experience in Quality Oversight of product transfer activities in a GMP environment.
- Demonstrated ability leading a complex team and influencing colleagues with no direct report relationship
- Hands on experience with change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
Physical Position Requirements
- This position requires sitting, standing, and walking with occasional overtime/weekend work.
- Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.