This job is archived
(Archived) QA Senior Manager External Operations
Job Description
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
QA Senior Manager External Operations
Virbac Animal Health is seeking a Quality Assurance Technical Manager for our Quality Assurance team. This position is directly responsible for the daily QA Oversight needs of the contract manufacturing organizations (CMOs), Suppliers for CMOs, Packagers, and Distributors utilized by Virbac North America. This is a highly visible position responsible for interactions with many companies and Virbac personnel across the Virbac NA, Virbac Headquarters (Carros, France), and Virbac affiliates
Benefits: 13 Company paid Holidays; 5 personal days (prorated); 15 vacation days (prorated); 5 floating holidays (prorated); 6% 401k match; competitive pay and bonus opportunity; growth opportunities and hybrid schedules based on department and role within the department and much more!
Area of responsibility 1: [CMO Oversight].
Main activities
This position is directly responsible for the daily QA Oversight needs of the contract manufacturing organizations (CMOs), Packagers, and Distributors, and material and component suppliers for both CMOs and the Virbac Bridgeton site, utilized by Virbac North America. This position is a working manager position that will be required to be actively engaged in problem solving, daily executions and project management. This position is responsible for the oversight of manufacturing and release of a wide variety of products, including drugs, supplements, medicated feeds, foods, and grooming aids.
Main activities
Develop relationships and systems with external organizations to ensure the appropriate level of quality is built into daily operations and the review/release process is in compliance with Federal (US and Canada), State, and local regulations
Understand all internal/external audit findings and industry trends and apply improvements as necessary at the (manufacturing) facility to facilitate continual improvement and sustainable systems in GxPs
A thorough understanding of the gaps within the operational system and define steps for improvement
Expected results: An efficient and GxP complaint SOP driven system managing suppliers, packagers, distributors, and CMOs
Area of responsibility 2: [Regulatory Expertise]
Main activities
Provides expertise and guidance in interpreting government regulations and implementing internal policies and procedures to ensure that Virbac remains in a state of compliance. Advises leadership on the appropriate resolution of issues posing a risk to the company. Must possess a thorough understanding of cGxP manufacturing requirements and best practices based on FDA, ICH, EU, local Board of Pharmacies, and related regulations.
Promotes corporate policies, quality standards and procedures, and brings methodological support and training for all functions that may have an impact on the quality of products and services.
Main activities: Provide leadership interpretation and application current cGxPs and related regulatory guidelines
Expected results: To ensure the application of quality policy, compliance with all regulatory expectations and standards.
Area of responsibility 3: [QA for Veterinary Food and Feed Products].
Main activities
Develop and maintain a quality system for QA oversight Virbac north America veterinary food and feed Products, inclusive of products produced at CMOs and the Bridgeton site
Main activities: Provide leadership for the review, revise, improve current processes, procedures, documents/paradigms to current cGMP regulations
Expected results: An efficient and GMP complaint SOP driven system supporting all veterinary food and feed products activities affecting Virbac NA
Area of responsibility 4: [Team Facilitation].
Main activities
Manage activities of direct reports by that fulfill the group’s roles, and provides both primary and secondary responsibilities for all activities
Creating individual development programs based on individual needs
Working collaboratively with all internal/external business partners and key stakeholders to assess project deliverables or project challenges to provide input on solutions utilizing strong interpersonal, influencing, and negotiating skills.
Expected results: Ensures project objectives are communicated to proper levels of the organization. Additionally ensure all escalated issues are resolved to ensure timely completion of the project. Create formal documented development program for direct reports
Profile
Requirements (Diploma and experience)
Bachelor's degree in Biology, Chemistry, Engineering or related field and experience
5+ years human or animal pharmaceutical Quality Assurance experience
10+ years human or animal pharmaceutical experience, with a preference for pharmaceutical quality experience.
Skills
Current knowledge of GLP, GCP, and GMP principles, local and international regulations and regulatory policies.
Demonstrated skill in effective team building, communicating with other departments, customers, employees at all levels of the organization.
Company Details
