Chris Ikeno
Head of Quality @Lonza
Signup · Get unlimited contacts
WORK HISTORY
Head of Quality @Lonza
Kingston, ON, CA
Key Responsibilities•Define and implement the Quality strategy aligned with business objectives, customer expectations and regulatory requirements•Lead the Quality organization, build high-performing teams, drive training/development, promote quality mindset and ownership culture•Oversee establishment, maintenance and continuous improvement of the QMS, ensuring compliance to cGMP, ISO, EMA and corporate requirements•Ensure inspection readiness: lead internal, customer and regulatory inspections; implement CAPA and improvements•Drive operational excellence in quality processes such as deviations, CAPAs, change control, risk management, metrics, data integrity•Act as the quality interface with customers, regulatory bodies, contract partners, and suppliers representing Lonza in quality and compliance matters•Partner with business leadership to balance quality, speed, cost and compliance, support new product launch, continuous improvement•Monitor quality key performance indicators (KPIs), drive root cause analyses and ensure robust trending and preventive actions•Budget resources and infrastructure for the Quality department, ensuring alignment with business growth and risk managementExperience•Extensive experience (10+ years) in quality leadership in a ISO/GMP regulated environment (biologics, medical devices, CDMO/CMO)•Deep knowledge of regulatory requirements (US, EU, Canadian), CE, ISO 13485, 9001, ISO 14971, change management and global quality systems•Proven experience building high-performing teams, developing talent, leading culture change and driving continuous improvement•Strong leadership, communication and influencing skills: ability to collaborate across functions and engage with senior stakeholders•Strategic mindset, commercial acumen and a pragmatic approach to balancing quality, cost and speed to market•Demonstrated track record of audit and inspection readiness, handling regulatory interactions, and driving improvement activities
EDUCATION
Seneca Polytechnic
3 year Diploma, Biotechnology (BTR)
Lonza
Certificate, Lean Six Sigma
Seneca Polytechnic
Pharmaceutical Regulatory Affairs and Quality Operations Grad. Cert., Regulatory Affairs
University of Guelph
H. B.Sc Honours Bachelor, Microbiology
SKILLS
ABOUT CHRIS IKENO
Dedicated and driven quality management leader with a proven track record•Strategically focused with a comprehensive approach to quality management ensuring business objectives are met or exceeded•Excellent interpersonal communication and problem solving skills •Intimate knowledge of Canadian and US good manufacturing practices, including ISO medical device standards for quality management (ISO 13485:2016), MDSAP (HC, FDA, TGA, MHLW) and European Medical Device Regulation (MDR, MDD)•Experienced with US Department of Defence requirements (EAR, ITAR, NIST cyber security)•Certified Lead Auditor (ISO 13485:2016, ISO 9001:2015, ISO 19011)
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.