Fabrizio Maniglio Email & Phone Number

Schaffhausen, Sh, Ch

Charlotte, North Carolina, Us

As an Industry Evangelist and Business Development Director at Honeywell, I bring 15 years of hands-on experience in quality and supply chain management within the life sciences sector. I am committed to: Executive engagement for business development and revenue growth. Driving innovation and thought leadership in the industry. Translating customer and industry needs into cutting-edge, value-driven products. Leading Customer Success and Executive Engagement initiatives focusing on digital transformation strategies. I continually monitor global healthcare, life science, and related consumer industry trends, partnering with thought leaders and regulators to proactively innovate.

Hamilton, New Jersey, Us

Hamilton, New Jersey, Us

Hamilton, New Jersey, Us

In my role as a Solutions Consultant at Sparta Systems Sales Team, I leverage my subject matter expertise in quality systems, quality life cycle and the life science industries to understand customer expectations in EMEA and help them find the best solution to address their need.I enjoy enabling our partners to increase their efficiency by deploying the right combination of Sparta Systems solutions.

Basel, Ch

- Data integrity assurance and computer system validation- Development and roll out local standards and systems based on global guidance and internal data integrity training- Lead quality aspects in a cross-functional team

Basel, Ch

- Has driven local supplier qualification program, including audits and quality agreement- Prepared and hosted all regulatory inspections and customer audits- Member of the QA Management team and Lead AuditorKey achievements:- Recruited and built a team of auditors to support internal, supplier and external audits, reducing audit preparation turnaround time by 50%- Developed KPIs and procedures to specifically measure performance of auditors and quality of audit reports, overdue actionable items reduced to 0.- Lead successful regulatory inspections by the US FDA, Health Canada, Turkish Ministry of Health, COFEPRIS and MHRA

Basel, Ch

- Accountable for the site quality strategy and quality customer interactions- Mentored local talent to develop into Head of QAKey achievements:- Successfully lead regulatory inspections by the US FDA for both Pharma and Dietary Supplements, and EMA (Germany)- Developed and initiated within 6 months a strategic QA transformation plan to increase performance and credibility of the quality unit

Basel, Ch

Manage all incoming deviation.Manage the deviation team (4 direct reports).Define priorities for the deviations.Responsible for training of the team.Lead the investigation into root cause.Investigate the impact on SISQP of the product.Identify the root cause(s) and define corrective and preventive actions (CAPA) together with the relevant functions.Write the deviation report in TrackWise.Responsible for the timely closure of the assigned deviation reports and related CAPAs.Define criticality of devaitionsTrack recurrence and reoccurrence.Trend deviations and identify systemic issues.

Basel, Ch

Lead the investigation into root cause.Investigate the impact on SISQP of the product.Identify the root cause(s) and define corrective and preventive actions (CAPA) together with the relevant functions.Write the deviation report in TrackWise.Responsible for the timely closure of the assigned deviation reports and related CAPAs.Define criticality of devaitionsTrack recurrence and reoccurrence.Trend deviations and identify systemic issues.

Basel, Ch

Lead the microbial QC support for the chemical API production, including development/adaptation of methods, training and release analytics.Investigate and write deviations in relevant areas.Plan method validation, including the creation and completion of validation plans and reportsResponsible for the safety concept of highly active - or sensitizing substances.Responsible for the temperature logging system for freezers and incubators.

M.Sc., Microbiology

B.Sc. Biology