Quality Manager R&D

Location: Bridgeton

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 area

s 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 area

s 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 (Diploma and experience)
** Bachelor's degree in Biology, Chemistry, Engineering or related field and experience
10+ years human or animal pharmaceutical experience, with a preference for…