Primary Function:

Responsible for the oversight of all Quality Assurance Operations in Vetio Animal Health’s Animal OTC facility in Jupiter, FL, including those related to Quality Assurance and the Quality Management System as well as the quality of all products produced. The Quality Assurance Manager will ensure compliance with all local, state, federal, company, and customer requirements and maintain current regulatory registrations, permits, and cGMP regulations as they pertain to 21 CFR part 210 and 211.

Key Responsibilities:

· Oversee and ensure compliance with all local, state, and federal regulatory requirements

· Oversee and ensure compliance with all company and applicable customer programs and requirements designed for production safe, quality products

· Ensure purity, quality, and composition of finished products

· Maintain the final authority to approve or reject all procedures, specifications, controls, test methods, and results that impact the purity, quality, and composition of ingredients or products

· Supervise and designate quality employee review and approval of all master manufacturing records, and all modifications to the master manufacturing records

· Assure use of the most current revision of all documentation

· Ensure the following Quality Programs are maintained according to cGMP standards:

o Corrective Action Preventative Action (CAPA)

o Deviation

o Quality Incident Reporting

o Complaint

o Change Control

o Training

o Internal Auditing

o Quarantine/On Hold

o Supplier Qualification and Foreign Supplier Verification

· Review and approve equipment, process, and cleaning validations

· Review and Approve laboratory control processes and testing results, as needed

· Review and approve the documentation for qualification of suppliers, both foreign and domestic

· Create, review, and sign customer quality agreements and other quality related documents

· Have the authority for disposition of raw material, in-process materials, finished products, and packaging materials

· Oversight of raw material, packaging, and finished product specifications

· Have the authority of control and release of withheld and retained product

· Responsible for hosting customer and regulatory auditors

· Responsible for responding to customer and regulatory audit observations

· Performs other related duties as assigned by management.

Skills & Knowledge Required:

• Bachelor's Degree (BA) from four-year college or university

· Extensive Knowledge FDA CFR 210 and 211 requirements

· At least 10 years’ experience managing a Quality Control and/or Quality Assurance group

· At least 10 years’ experience in FDA/GMP environment

· GMP Professions certification preferred

· Experience communicating with customers

· Experience hosting and/or participating in regulatory audits

· Ability to manage multiple projects and prioritize demands

· Strong organizational skills

· Strong analytical skills with attention to detail

• Self-starter/motivated
• Computer skills preferred: Microsoft Office Suite, Project Management Software, SAP, QMS

Supervisory Responsibilities:

• Directly supervises employees within the Quality department.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.