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Sr Manager, Audits and Inspections @Boehringer Ingelheim
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WORK HISTORY
Sr Manager, Audits and Inspections @Boehringer Ingelheim
San Francisco, CA, US
Site contact and SME for client audits/inspections. Leads site inspection readiness activities, client audit/inspection logistics and back-room operations.Drives awareness of GMP requirements, communicates with regulatory and international agencies and ensures industry trends/regulatory requirements are followed at the site. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas. Leads and manages activities associated with inspection readiness for manufactured drug products, including biologics drug substance and drug products, medical device/combination products.• Lead and coordinate commitments and associated CAPA to health authorities, clients as well as corporate and internal auditors. • Provides process and system training for site staff involved in client audit/inspections, balancing training offerings with site demands. • Leads and improves Quality Systems and / or cross-functional Key Performance Indicators.• Establish and improve new and established network alignments (e.g. Corporate, Bio).• Lead local/divisional global process improvement teams.• Pro-actively uncover issues and concerns relating to quality systems and leads resolution and continuous improvement with functional/cross-functional team. • Engages local, divisional and global network to ensure alignment with Boehringer Ingelheim standards and related operating units. • Provides expertise to the site and division to the audits/inspections.• Influences local and divisional network based on knowledge and experience within Quality Systems. • Hires and develops talent to ensure support to commercialization and continuous improvement of the Quality Organization.• Establishes cross-training activities and back-up efforts within Quality Systems.• Annually assesses group tasks and completes accurate resource planning.
EDUCATION
University of Ibadan
PhD, Molecular Virology
ABOUT ADETUNJI AKANO
Adetunji (Sunny) Akano holds a Doctorate degree (PhD) in Molecular Virology from The University of Ibadan, Nigeria. He worked total 3 years as a Postdoctoral scientist at International Center for Tropical Agriculture, Cali, Colombia, South America and Donald Danforth Plant Science Center, St. Louis Missouri, USA. He has over 20 years\' experience in Quality Systems and compliance from pharmaceutical drug, Biopharmaceuticals, Biologics, medical device/Combination products, medical devices, cell gene therapy, Blood banking, Animal pharmaceutical, and nutraceuticals industry. Adetunji is ASQ Certified Quality Auditor since 2010.Expert resource for evaluation of Organizations Quality Management Systems in compliance with Regulatory requirements – ICH Q7, OSHA, DEA, ISO 9001, ISO 13485, 98/79/EC, SOR/98-282, Australian TGA, MHLW Ministerial Ordinance No. 169, MHRA, PMDA, EU and FDA 21 CFR Parts 4, 11, 110, 210, 211, 312, 314, 606, 607, 610, 820.
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