Michael Bless Email & Phone Number

Durham, NC, US

Wilmington, North Carolina, US

Responsible for the quality assurance and compliance functions by managing, planning, scheduling, overseeing, and conducting GCP Quality Assurance activities. Responsible for leading auditing activities (internally and externally) to ensure that quality and data integrity are maintained according to monitoring plans, GCPs and ICH guidelines.

Boston, MA, US

• Key role in ensuring the currency and proactive strategies for the QMS design and practices, adherence with evolving regulatory requirements and in ensuring readiness for meeting emerging business needs originating.
• Leader of the GCP Regulatory Surveillance program. Training on updates and GCP LT reporting
• Supported the QMS intelligence program by identifying QMS leading practices, emerging trends, progressive strategies, and proactive quality risk management approaches.
• Supported QMS design and improvement activities (process mapping, root cause analysis, etc.).
• Document Control and Training facilitator. Project-managed the cross functional and GxP wide assessment of training assignments for compliance and to identify required/potential update needs.
• Acting Business owner of the GxP Veeva Event Management and Change Control module (eQMS).

• Working for clients in CRO and Pharmaceutical Industry. Services/deliverables provided:
• Pharma/Biotech: Advanced GCP support: Consolidated the supplier audit schedule and added automated trending reports; CAPA review and resolution support.
• Pharma/Biotech: QA advisor for clinical trial process analysis and improvement (multiple workstreams). Design of a Work Breakdown Structure for clinical trials and linking the WBS tasks to a regulatory reference matrix.
• CRO: Redesigned and implemented supplier classification, assessment, and maintenance program. Implemented an electronic CAPA and Audit tracking systems to obtain metrics and trending data.
• CRO: Led the migration of the eDMS and eLearn content to a new platform (new provider).

Marlborough, Massachusetts, US

QA leadership and responsible for the overall QMS development. Focus on team integration and quality process harmonization of the new company Aptiv Solution, which has been founded as a new entity based on the merger of Averion International Inc., Addplan GmbH, ClinResearch GmbH, Fulcrum Pharma Ltd., Niphix (Japan), Trio Clinical Research, SRA.

At mid-size CRO (pharmaceuticals, medical devices) established and maintained an overall quality management system in a post merger environment (Averion and Hesperion). Global team building and introduction of a global internal and project focused risk-based audit program. Leading the implementation of global SOPs, CAPA process and global supplier.

Dublin, IE

Various QA functions: Starting initially as a QA Manager with QA responsibility for audits in Germany, then assumed responsibility for implementation of the global Corporate Systems Compliance unit within ICON's QA department. Lead of the overall QMS function with focus on internal system audits, supplier audits and ISO 9001 registration, QMS integration.

- Parental leave according to German work laws.- Contract work for GWD GmbH (Data Management, data entry coordination and oversight)- Training to obtain registration in Quality Management (ISO 9001) at TÜV Akademie Rheinland

• Data management plan, system set-up, statistical analysis (SPSS), and statistical report writing.
• QA responsibilities (peer auditor) from 1993
• Lead of DM team from 1994