Michael Bergin Email & Phone Number

Boston, MA, US

Strategic Consulting: 20+ years of successful experience in assessing organizations, resources and systems and developing a highly functional team and processes that drive efficiency and collaboration through the organization, focusing on cost savings/cost avoidance and efficiency. cGMP and cGCP Quality Support: 50 years combined of cGMP/cGCP expertise.

Burlington, Massachusetts, US

Provides oversight of all aspects of the company’s drug manufacturing processes including production being undertaken by Contract Manufacturers (CMs). Provides support pharmaceutical/medical device manufacturing and compliance. Building out a team as the needs of the company grow over time. Plans and directs commercial manufacturing operations and.

Providing leadership for the Quality function (Quality Systems/Quality Operations/Clinical Quality Assurance/Quality Control) through development and implementation of the overall quality systems and processes ensuring compliance through a strategic plan in preparation for product launch.

• Providing leadership for Quality Systems & Compliance (QS&C) function through development and implementation of the overall quality systems and compliance strategic plan in preparation for product launch. The QS&C.
• Planning, developing and manageing QS&C departmental budget
• Promoting a culture of humility, quality, compliance and accountability mindset, including continuous improvement through the establishment of KPI metrics and reporting.
• Hosting regulatory inspections and third-party audits, and lead inspection readiness activities.
• Managing the internal, external and supplier audit program.
• Establishing and maintaining a robust program for safety reporting, complaints, product recalls and product retrievals.

• Responsibilities-Quality Oversight of Pharmaceutical/Device Quality Assurance facilities located in Ogden UT, Guadalajara MX, Knoxville TN and Waltham MA. Quality Oversight of Concentrates facilities located in Irving.
• Providing strategic leadership of overall objectives through the application of thoughtful techniques in the communication of the company's mission and core values to effect positive change and/or create organizational.
• Leading operational efforts to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s).
• Directing and oversight the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and procedures relevant to the assigned functional area(s).
• Managing the Quality Operations aspects of Fresenius Medical Care/Renal Therapies Group (FMCRTG) Pharma Manufacturing, Supply Chain, and Concentrates sites.
• Working closely with operations counterparts to assure continuous improvement and regulatory compliance are maintained at the sites.

Bad Homburg, Frankfurt, DE

• Responsibilities-Oversight of Pharmaceutical/Device Quality Assurance located in Ogden UT, Guadalajara MX, Knoxville TN and Waltham MA
• Responsible for ensuring that the quality systems are effectively established and maintained according to corporate policies and procedures, and all applicable local, state, federal and international requirements.
• Assuring that the Pharmaceutical facility’s Quality program is established, effective and maintained in compliance with applicable local ordinances, State statutes and Federal regulations, and other laws, including.
• Establishing systems to monitor the quality initiatives and Quality system outputs for effectiveness and efficiency. Working with Corporate, Plant and QS management to develop budgets and long-term planning. Creates.
• Developing and maintaining fiscally responsible budgets, driving the organization to meet or exceed budgetary commitments while achieving compliance and product quality goals.
• Maintaining a highly effective organization, with personnel who are appropriately skilled and motivated to contribute to the success of the company.

Bad Homburg, Frankfurt, DE

• Responsibilities-Oversight of Concentrates manufacturing sites in Oregon, OH, Montreal CA and Irving TX, and 14 US Distribution Centers, 50 cross docks and Waltham MA Pharmaceuticals
• QS Management of 3 Concentrate Manufacturing facilities, 8 Contact Manufacturing Organizations and testing facilities, 14 Distribution Centers and over 50 cross-docks.
• Managing all Quality Systems aspects of the Renal Drug Initiative. Ensuring Quality System and process controls are in place for the renal drug product and adequate QC controls are in place for batch release.
• Ensuring Quality Systems are established for qualifying new CMO and/or API manufacturers.
• Development, review, and improvement of pharmaceutical contract manufacturer’s Quality Plans and manufacturing processes related to FMCNA-RTG drug products.
• Ensuring that the contract pharmaceutical facility’s Quality Systems are established and maintained in compliance with applicable local ordinances, State statutes and Federal regulations, and other laws, including.

Bad Homburg, Frankfurt, DE

• Directly managed 4 CAPA Engineers/specialists and Corporate CAPA Review Board (CCRB) activities for optimized success.
• Corporate SME for CAPA and Non-Conformances, managed the Corrective Action and Preventive Action (CAPA) systems and process activities.
• Ensuring compliance to requirements and the consistency/quality of CAPA execution across all FMCNA sites.
• Driving timely execution of CAPA and NC deliverables through monitoring and reporting status to CAPA owners and management.
• Interfacing with management, peers and subordinates to assess and improve the adequacy of the processes. This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections.
• Developing and delivering CAPA and NC process training as required ensuring the appropriate level of the process knowledge is maintained.

Lawrence Township, NJ, US

• Responsible for directing quality oversight of start-up activities including PAI Readiness activities, auditing, QS, recordsmanagement, Supplier Quality Management and associated processes.
• Directing quality oversight for training, Supplier Quality, auditing, CAPA, records management, quality systems, regulatory communications, audit observation oversight, and annual product reviews.
• Participating in the initial regulatory reviews and approvals of the facility and products and manages the internal cGMP audit function to ensure that the site meets current regulatory and BMS corporate requirements.
• Managing the Supplier Quality Agreements program to ensure that raw materials suppliers, services suppliers and equipment vendors meet applicable regulatory and company requirements.
• Ensuring all current vendors are qualified and conducting audits at defined frequencies as part of the vendor monitoringprocess.
• Managing the Records Management System and Record Retention Program for site procedural documentation.

Lawrence Township, NJ, US

• Providing oversight, direction and guidance to two managers and 25 (15 FTE and 10 contractors) quality operations professionals
• Developing, implementing and directing operating procedures for the site quality assurance program which assures effective shop- floor quality presence; material release (raw and in-process materials as well as.
• Directing the quality oversight of start-up activities including approval of batch recipes, testing methods and associated process, and laboratory technical documentation.
• Directing the QA support for ongoing validation activities for equipment, cleaning, sterilization, and process qualificationand validation.
• Directing disposition of Final Bulk Drug Substance (BDS)
• Participating in the site team that prepares for, hosts and responding to regulatory inspections, reviews and approvals of the facility and products.

• Provided oversight of Phase 2 clinical trial and of all GxP global quality operations while focusing on continuous process improvement.
• Implemented, managed and provided oversight of quality programs such as change control, process specifications, review and approval of batch records, labeling, GxP CAPA program, etc.
• Provided oversight of quality documentation systems with archival of quality documents such as change control, SOPs,protocols/reports.
• Developed a global (internal and external) audit program and an associated CAPA management program ensuring all non- compliant conditions were remediated.
• Developed a centralized system for the oversight of quality agreements.
• Lead the implementation of a quality system assuring that products manufactured are in compliance with cGMPs, including the US, EMA, and ASEAN regulations and prepared quality document packages required for IND.

US

• Responsible for all elements of Quality Assurance Department supporting two commercial pharmaceutical products.
• Maintained collaborative relationship with Oscient international and domestic CMO’s and Contract test labs by representing a lead role in Oscient’s management of internal/vendor quality, ensuring the quality of.
• Establishing and administering Oscient’s 3rd party manufacturers’ quality system, the establishment and oversight of requirements, workflow and metrics for the quality assurance activities between Oscient and global.
• Oversight of day to day quality operations including but not limited to lot release, change control, investigations, CAPAs, stability programs and other quality systems controlling improvements in a cGMP environment.
• Providing oversight of technical transfer to contract sites utilizing a risk-based approach for transfers and to actively identify risks to the program and develop corrective action plans to address risks.
• Providing compliance support to CMO during EMEA/Pre-approval inspection.

New York, New York, US

• Served nine months as the DQU Compliance Manager, providing compliance oversight of quality systems, manufacturing, aseptic filling, testing and storage facilities.
• Development, implementation and execution of a risk based Internal and Supplier Audit/Qualification Program, which includes the performance of internal, vendor and qualification audits, in coordination with Global.
• Composing and issuing audit reports to senior management and conducting follow up on internal and external audit action items and investigations.
• Creation and Oversight of the audit CAPA system ensuring closure and follow-through of internal and regulatory commitments.
• Metrics reported to Site Quality Council.
• Creation and delivery of training on new/revised Quality Systems, supporting facility certification programs at Wyeth BioPharma and contract manufacturer sites.

• Providing guidance and direction to one directly reporting individual in the role as the Group Team Leader of the Regulatory Compliance Department supporting solid oral dosage generic drug manufacturing.
• Composing, reviewing and issuing audit reports and conducting follow up on internal and external audit action items as well as conducting internal compliance investigations.
• Execution, Oversight and Management of the site CAPA system, ensuring commitments were closed on time, according to the action plan and verified as effective. Incorporated metrics to identify CAPA trends requiring.
• Drafting and execution of the annual systems audit schedule and related audit procedures, management and hosting of all external audits (including Regulatory Inspections).
• Development and implementation of the audit corrective action tracking/trending database, ensuring project deadlines and performance standards are established and met.

• Oversight and management of the daily functions of seven directly reporting QA Inspectors/specialists.
• Management and oversight of all functions of QA Compliance Specialist/Auditor listed below.
• Creation and Management of the CAPA system, ensuring audit commitments were verified and closed on time. Provided a mechanism to notify CAPA owners of commitments one month prior to due date, resulting in significant.
• Disposition of final product, products for further manufacturing and raw material/labeling materials to production, providing quality oversight of manufacturing and aseptic filling processes, reporting metrics for.
• Performance of internal annual audits of all manufacturing and testing facilities, external supplier and qualification audits.
• Preparation and submission of audit reports to senior management, management of the weekly cGMP surveillance audit program for manufacturing facilities and laboratories, management and maintenance of the CAPA database.

Responsible for staffing and oversight of all manufacturing operations.