(Archived) AD, Regional Quality Biologics NA - 2 years contract role

Description

This is 2 years BI Contract role. This role can be based out either in Athens, GA or Saint Joseph, MO.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The AD, Regional Quality Biologics NA supports the Animal Health Global Supply manufacturing sites in North America in all compliance and quality initiatives, topics and projects. This role will maintain oversight of global and divisional procedures implementation at the sites in close collaboration with the Site Quality Head and related MSOs. The incumbent provides guidance towards procedures/process implementation and serves as connection between Sites, AH Global Quality Services team and PIN/RIN processes. The AD, Regional Quality Biologics NA may act as Divisional MSO, ensuring implementation of the respective Quality System throughout the AH Sites. The incumbent monitors and supports Local Quality Roadmap (or similar) implementation as well as leads and/or contributes to specific Global AH Quality projects. This role drives continuous improvement and supports the development of the Quality Culture within BI.

Duties & Responsibilities

• Provides technical and managerial support to the sites by contributing/leading root cause analysis, investigations, corrective actions implementation, as well as audit preparations and respective CAPAs follow up.
• Responsible for ensuring appropriate and up to date overview of global/ divisional procedures implementation at the local sites is available.
• Maintains close collaboration with the Sites and MSO network.
• Coordinates feedback collection from the sites/network to support PIN/RIN processes.
• Contributes with technical knowledge to the review of AH related procedures.
• Exerts the divisional ownership of the respective Quality Management System, assuming the role of Div. MSO. Liaison with the respective global and local MSOs.
• Maintain respective divisional document landscape, in alignment with global procedures.
• Provides consultancy and support of quality/GMP compliance status for AH sites and CMOs, around responsibility.
• Drives for continuous improvement.
• Monitors execution and performance of the respective Quality System with adequate KPIs.
• Ensures escalation to management.
• Acts as project leader for or represents AH Quality within high priority (large and/or complex) projects.
• Defines project objectives & approach during the evaluation phase.
• Ensures that the project is executed in accordance with and delivers the results in accordance project plan and scope.
• Ensures that the project cost is kept within the agreed budget.
• Ensures that the project plan is re-evaluated, adjusted and re-negotiated at regular intervals, or when internal data or external information suggests that the timeline may slip, or certain objectives may not be met.
• Proactively manages and foresees project risks, ensures identification and implementation of mitigating action as necessary.
• Keeps team members and stakeholders informed of key developments, program decisions, issues, and changes to the project and the project plan.
• Regularly reports the project progress, status and potential mitigation actions in case of critical deliveries to decision making bodies (e.g., steering committees.)
• Responsible for "positive" management of the project team, i.e., leading effectively to enable necessary progress, performance and quality of the work packages.
• Ensures effective stakeholder management.
• Participation in BI working groups to define veterinary position.
• Participation in inter-company working groups to represent BIAH Quality position (in accordance with BI Regulations).
• Establishes a knowledge management platform and concept for the Region and drives knowledge management sharing across the Sites.
• Supports Divisional QMR preparation in close collaboration with the Sites and AH Quality leadership team.
• Complies with the relevant (BI internal) safety guidelines and specifications in the working environment.
• Strives for and supports zero accidents.
• Performs safety measures according to internal requirements.
• Ensures continuous improvement.

Requirements

• Bachelor's degree in Microbiology, Chemistry, Biology, Engineering or related discipline is required; an advanced degree in Pharmacy, MS or PhD is preferred.
• At least eight (8) years of professional experience in Quality management within a Pharmaceutical company working under FDA, USDA, EU GMP and other major countries regulations at a senior level.
• Deep knowledge in various technologies, both in (sterile products), Bio (bio generators, monolayers, ovoculture).
• Excellent knowledge of applicable international GMP requirements, e.g., FDA, USDA, EU GMP, China GMP.
• Capability for strategic and conceptual work (concept definition and communication) and cross-functional, cross-cultural alignment).
• Ability to successfully drive compliance initiatives and programs.
• Excellent written and oral communication skills.
• Strong decision-making skills.
• Strategic vision and leadership, influencing and negotiating skills with top managers within the Company and with various Agencies heads and representatives at worldwide level, i.e., with various cultures
• English: read (fluent), write (fluent), speak (fluent).
• Experience in leading large projects.
• Profound project management, coordination, influencing and negotiation skills.
• Ability to solve conflicts.
• International experience: International exposure in daily business (> 50% of international business/customers /staff).
• Leadership competencies: AAI.

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.