Ayse Kivilcim
Senior Quality Manager, External Manufacturing North America @Reckitt
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WORK HISTORY
Senior Quality Manager, External Manufacturing North America @Reckitt
Salt Lake City, UT, US
Responsible for quality oversight and compliance of health and hygiene external manufacturing partners across North America. Ensures that third-party manufacturers of Reckitt’s Health Products (e.g, Mucinex, Biofreeze, Delsym, Airborne, MegaRed, Clearasil, Move Free) and Hygiene Products (e.g, Lysol, Finish) meet Reckitt corporate quality standards and Reckitt regulatory requirements along with meeting CFR – Code of Federal Regulations Title 21 US regulations (e.g, 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR Part – Current Good Manufacturing Practice in Manufacturing, Packaging, Labelling, or Holding Operations for Dietary Supplement, 21 CFR Part 820 – Quality System Regulation (Medical Device). Drives continuous improvement and supports business growth through proactive quality management and cross-functional collaboration. Key priorities / result areas in the role:• to bring strategic advantage and drive performance for Reckitt by unlocking opportunities, enabling innovation and proactively identifying & mitigating risks within EMO Sites. Together, to build trust and to protect our consumers, employees, and position Reckitt to deliver on our shared purpose. • developed a high performing team of quality professionals within the North America EMO Organisation collaborating as key business partner, shape quality strategies, with cross functional global key stakeholders & external manufacturing organization to achieve the desired business results. • people leader actively engaging in developing and nurturing high performing teams and growing talents with high potential to take up challenging leadership roles within R&D, supply & quality. • orchestrated a Robust External Manufacturing Quality Strategy with 5 key pillars of Compliance, Consumer Centricity, Digital Capability, Culture & People with a diversity & inclusion agenda.
EDUCATION
Yıldız Teknik Üniversitesi
Bachelors of Science, Chemical Engineering
ABOUT AYSE KIVILCIM
Personal Profile & Key SkillsDevelop Quality Management Systems including policies, procedures and working practices regarding different fields; pharmaceutical industry, medical devices, cosmetics, general products.A committed and focused professional experienced across a wide range of pharmaceutical, medical device and cosmetic processes. Highly motivated to make a significant contribution in the work place and job responsibilitiesCommunicator and team player with a positive attitude to deliver results in a challenging environmentSupervision and coaching experience of pharmaceutical staff including production, quality, techniciansLead the audits performed within the pharmaceutical and engineering industrySuccessful regulatory and customer inspection experience for new and existing productsRobust knowledge of ISO, EU, WHO, FDA, GMP regulations and GMP risk management techniquesISO 9001, 14001 and OHSAS 18001 Auditor Lead activities related to processes and optimization and help identify and analyze issues that affect the company’s growth and profitabilityDevelop strategy and business plans for focused business areas and portfolio, recommend risk tolerances and risk mitigation strategies
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