Quality Manager R&D

Virbac•Bridgeton, MO

About The Position

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. This position is directly responsible for the daily R&D Oversight needs of the Bridgeton manufacturing site and contract manufacturing organizations (CMOs), 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. Area of responsibility 1: [ QA for Internal R&D ]. Main activities Maintain and improve the quality system for QA oversight of Virbac Bridgeton R&D, inclusive of GLP and GMP activities at Virbac Bridgeton site. Review/approval of R&D procedures as well as Validation plans, protocols and reports Implement and manage corrective actions when necessary. Schedule, supervise, and conduct audits to support R/D functions, as required. Audit R&D documents and practices. Manage and issue final audit results. Provide guidance to R&D Functional areas to develop / enhance their processes. Expected results: An efficient and GxP complaint SOP driven system supporting all R&D activities affecting Virbac NA Area of responsibility 2: [ QA for External R&D ] Main activities Maintain and improve the quality system for QA oversight of Virbac R&D for North America, inclusive of GLP and GMP activities at CROs, CTL, CMOs, and other contract organizations used to support product development Implement and manage corrective actions when necessary. Schedule, supervise, and conduct audits to support R/D functions, as required. Audit R&D documents and practices. Manage and issue final audit results. Provide guidance to R&D Functional areas to develop / enhance their processes. Expected results: An efficient and GxP complaint SOP driven system supporting all R&D activities affecting Virbac NA Area of responsibility 3: [ Regulatory Compliance ]. Main activities This position is directly responsible for QA Technical functions within the R&D department, including ensuring development projects are implemented per established regulatory policies and meet all regulatory requirements for all applicable government agencies. Ensure R&D and Quality Control (where applicable) Laboratories meet industry and Virbac standards set forth by Regulatory agencies and Virbac. Serve as QA reviewer and approver of R&D release, stability and raw material data (analytical ~ 90% and microbiology ~ 10%) Serve as QA reviewer and approver of laboratory equipment and method validation protocols/reports to ensure adequacy and completeness Review and approve R&D OOS/OOT investigations for raw materials, intermediate and finished product testing. Track investigations and report regularly to upper management. Provide QA reviews and approvals of R&D procedures, methods, deviations and other documents, as necessary. Expected results: Ensures R&D and Quality Control (where applicable) meet Virbac and Regulatory requirements Area of responsibility 4: [Team Facilitation] Main activities Partner with other members of Quality Assurance North America and Corporate Quality Assurance to facilitate completion of the QA workload from R&D activities. 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. Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/Risk Management, Clinical Operations and Regulatory to ensure appropriate cross-functional SOPs, policies or work instructions are in place. Provide regular updates to management functions and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships. Expected results: Facilitate cohesive interaction between respective groups to ensure projects and processes are maintained in a compliant manner.

Requirements

Bachelor's degree in Biology, Chemistry, Engineering or related field and experience 10+ years human or animal pharmaceutical experience, with a preference for pharmaceutical quality experience.
Current knowledge of GLP and GMP principles, analytical and validation 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.
A Manager manages experienced professionals who exercise latitude and independence in assignments.
Policy and strategy implementation for short-term results (1 year or less).
Problems faced are difficult to moderately complex.
Influences others outside of own job area regarding policies, practices and procedures.

Responsibilities

Maintain and improve the quality system for QA oversight of Virbac Bridgeton R&D, inclusive of GLP and GMP activities at Virbac Bridgeton site.
Review/approval of R&D procedures as well as Validation plans, protocols and reports
Implement and manage corrective actions when necessary.
Schedule, supervise, and conduct audits to support R/D functions, as required.
Audit R&D documents and practices.
Manage and issue final audit results.
Provide guidance to R&D Functional areas to develop / enhance their processes.
Maintain and improve the quality system for QA oversight of Virbac R&D for North America, inclusive of GLP and GMP activities at CROs, CTL, CMOs, and other contract organizations used to support product development
This position is directly responsible for QA Technical functions within the R&D department, including ensuring development projects are implemented per established regulatory policies and meet all regulatory requirements for all applicable government agencies.
Ensure R&D and Quality Control (where applicable) Laboratories meet industry and Virbac standards set forth by Regulatory agencies and Virbac.
Serve as QA reviewer and approver of R&D release, stability and raw material data (analytical ~ 90% and microbiology ~ 10%)
Serve as QA reviewer and approver of laboratory equipment and method validation protocols/reports to ensure adequacy and completeness
Review and approve R&D OOS/OOT investigations for raw materials, intermediate and finished product testing.
Track investigations and report regularly to upper management.
Provide QA reviews and approvals of R&D procedures, methods, deviations and other documents, as necessary.
Partner with other members of Quality Assurance North America and Corporate Quality Assurance to facilitate completion of the QA workload from R&D activities.
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.
Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/Risk Management, Clinical Operations and Regulatory to ensure appropriate cross-functional SOPs, policies or work instructions are in place.
Provide regular updates to management functions and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.