Boehringer Ingelheim · 17 hours ago
SR AD, Quality And Compliance
Gainesville, GA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expBoehringer Ingelheim is a global company committed to improving the lives of patients and customers. The Senior Associate Director, Quality And Compliance will oversee Quality Assurance, Quality Control, and Validation functions at the Gainesville Manufacturing Site, ensuring compliance with regulatory standards and maintaining inspection readiness.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
Pharmacist, Veterinarian, or Bachelor of Science in Chemistry, Microbiology or other life science from an accredited institution
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
Preferred
Master of Science in related field preferred
Benefits
Competitive compensation and benefit programs
Support our employees in a number of ways to foster a healthy working environment
Meaningful work
Mobility
Networking
Work-life balance
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10001+ employees
H1B Sponsorship
Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (4)
2023 (11)
2022 (7)
2021 (17)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
Corp. SVP BioPharma Network
Clemens Twardy
Corporate Vice President, Head of Global Supply Chain and Lifecycle Management Animal Health
Recent News
2026-01-23
Hindu Business Line
2026-01-22
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