SR AD, Quality And Compliance

Description

The position has overall responsibility for Quality Assurance, Quality Control and Validation functions at the Gainesville Manufacturing Site including the development and implementation of both Quality Policies and Systems at the site. In addition, this position manages the overall inspection readiness, inspection management and ensures the Operations Team maintains existing manufacturing licenses and supports extensions and initial registrations. The position is responsible for execution and implementation of Global Quality procedures and processes. 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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Implement Quality and Compliance initiatives and strategic improvements and support the Gainesville Site in all Quality and Compliance projects and innovations.
• Ensure continuous improvement of the Gainesville Site Quality concepts, promote innovation, best practices and system performance.
• Provide appropriate training and support for the preparation and realization of inspections at the Gainesville site. Management of regulatory inspections and global/corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors.
• Development of staff and talent pipeline planning for the Quality organization at the Gainesville site and assist in developing the performance management systems for Quality at the Gainesville site.
• Ensure appropriate quality, oversight, input and support for business projects, e.g. new business integration.
• Oversee Quality Risk Analysis at the site in order to define action plans to mitigate critical risks.
• Drive the overall Quality elements for the sites Quality Integration, Strategic Capital Investments, New Product Development, and technology transfers including serving as the primary interfaces with Regulatory Affairs and associated Regulatory Agencies.
• Follow related USDA, EU, Russian and other GMP Biological updates and define strategies of implementation at the Gainesville site for the >90 countries served to include regulatory compliance, renewals, and projects. Including implementation of required Corporate Quality and AH Global Quality procedures and polices.
• Maintain a good understanding of the latest regulatory requirements of the countries served by the Gainesville Site.
• Direct Quality Risk Analysis program at the site in order to define action plans to mitigate critical risks.
• Provide technical-regulatory expertise to multidisciplinary projects for production transference or for new drug products.
• Provide technical-regulatory expertise to review document to be submitted in regulatory agencies as well as revising the responses to incomplete letters or requirements linked with regulatory agencies.

Requirements

• Pharmacist, Veterinarian, or Bachelor of Science in Chemistry, Microbiology or other life science from an accredited institution.
• Master of Science in related field preferred.
• At least ten (10) years of experience working in operations, Quality Assurance, and / or Quality Control in regulated medicines environment required.
• Strong experience with EU and USDA inspections and regulations.
• Expertise in USDA and in EU GMP
• Expertise include advising on national and/or international public health and science programs for vaccines, medical products or food; analyzing national and/or international policy/regulatory issues regarding vaccines medical products or food and recommending appropriate course of action; and participating in negotiations with agencies
• Functional knowledge of laws, regulations, regulatory agencies and industry best practices is required.
• Functional knowledge of medicinal products, especially biological, devices manufacturing and testing is required.
• Internal (audit corrective and preventive action assignment, projects prioritization) and external (inspections corrective and preventive actions) negotiation skills are required.
• Functional knowledge of Corporate/Global internal requirements and documentation.

Desired Skills, Experience and Abilities