Joseph P. Brennan
Doylestown,PA
Summary
Expertise in: Pharmaceuticals | Biotechnology | Medical Devices Areas of Expertise: Quality & Regulation | Operational Excellence | Internal Audit | Analytical Thinking | Global Compliance Change Management | Project Management & Execution | Business Model Creation | Team Development | Mergers & Acquisitions | Program Enhancement | Process Improvement Execution | Whole company Integration
Overview
25
25
years of professional experience
Work History
Head of Quality Transformation
Royal Phillips
- Integrated Supply Chain Quality & Regulatory (Q&R) Operations, Global 500 organization ranked in the top 10 largest healthcare companies
- Primarily focused on technology and engages in healthcare, lighting, and consumer well-being markets
- Promoted to role and tasked with developing analytical capabilities to identify and drive productivity across business segments with focus on Q&R teams, clusters, and markets
- Increased manufacturing productivity to save >$10M+ in cost avoidance annually by implementing robotic process automation (RPA)
- Participated as a member of the Quality Operations Leadership team, accountable for scrap reduction, streamlining audit processes, standardizing calibration, verifying EU MDR, and improving acceptance activities and change control.
Director, Chief Information Officer
Johnson & Johnson
- Medical Knowledge Management, Global Process Improvement, Worldwide IT Operations, Medical Devices, & Diagnostics
- Bioclinica
Assistant Director
GlaxoSmithKline
Regional Manager
Merck & Company
RA Project Leader
Johnson & Johnson/Depuy Synthes, Global UDI and EU EUDAMED
06.2023 - Current
- Assigned to support a team within Regulatory Operations that is centralizing work related to EU MDR and ensuring that the processes and systems will be optimized to handle the additional workload
- Responsible for driving the overall project within Regulatory Operations, including report-outs to management, communicating metrics, and ensuring the programs are within budget
- Worked closely with franchise regulatory partners and Regulatory Operations partners
- Oversaw and assisted in the collection of UDI-related master data for submission to UDI databases
- Supported and advised on regulatory requirements for UDI direct part marking compliance
- Provided the regulatory UDI requirements for applicable countries
- Conducted and documented UDI regulatory assessment (including the impact of the change on UDI databases and labeling) of product changes.
Senior Director
GE HealthCare
01.2023 - 06.2023
- Entrusted to manage and improve current capabilities, overcome business challenges, improve medical devices across multiple modalities, and drive compliance across regulatory standards to strengthen decision-making and align with industry trends
- Spearheaded the establishment of a pre-integration assessment process for newly acquired companies, evaluating risks to GE and ensuring smooth integration; assessed multiple companies using the newly established process, continually refining its effectiveness
- Innovated and implemented a robust risk ranking mechanism for all manufacturing sites, adhering to ISO 13485 CFR 21 820 standards, enhancing auditors' ability to identify critical areas and significantly improving audit precision
- Elevated the quality of audit reports by providing meticulous peer reviews, contributing to the enhancement of findings and observations
- Collaborated effectively to help oversee audit responsibilities, maintaining seamless operations and continuity in audit processes
- Ensured the robustness of the GEHC Quality Management System by defining, tracking, and maintaining key metrics, offering early visibility of Quality and Regulatory issues to Central Quality management.
Global Head
SmithKline Beecham
01.2018 - 01.2021
- Key lead in the merger of Glaxo Wellcome and, , selecting processes, Laboratory, IT, and Manufacturing Systems, and personnel needed for day 1 of the newly formed GlaxoSmithKline (GSK)
- Key lead in the assessment and subsequent acquisition of two companies (Amic and Immunicon) into the family of Johnson and Johnson companies (infrastructure, operations, processes, cGxP compliance, finance)
- Led the Immunicon integration project post-acquisition
- Established Integrations function within Philips Quality & Regulatory for post-acquisition integration of companies onto the Philips Quality Management System; authored the M&A Playbook to include desk audits of target companies ensuring Business Development would be educated in the risk and potential costs of remediation of acquisitions post-deal close
- Authored M&A Playbook for GE Healthcare and onboarded two acquisitions, Caption Medical and Imactis
- Conserved Johnson & Johnson more than $50M by proper management of an international team to drive global budget reduction initiatives, which included Leaning out manually intensive/error-prone processes, unlocking resource capacity through process improvements, and reducing expenses
- Grew Bioclinica (now Clario) start-up revenue from $50M to $95M in less than one year by establishing standards, policies, procedures, headcount, and budgets., Quality & Regulatory, Compliance & Audit |, Accepted role permanently to implement audit strategy companywide
- Leveraged previous experience and knowledge to provide risk mitigation solutions on identified control inefficiencies
- Established cohesive internal audit programs by building high-performance teams and promoting professional development
- Sustained regulatory compliance by adjusting codes as needed and communicating to all stakeholders which changes were being implemented
- Prepared organization with documentation and personnel support that met company standards and adhered to regulatory compliance policies for annual risk assessment, audit plan, and schedules
- Oversaw 42 direct and 400 indirect reports tasked with planning, testing, supporting, and validating appropriate controls for internal and external audits
- Regulated quality and workflow of mergers and acquisitions, including introducing internal audit to due diligence process, which saved millions of dollars, prevented failing company acquisitions, and expanded company growth
- Authored the Philips Q&R M&A Playbook for handling target company acquisition pre- and post-deal finalization
- Sustained compliance for 510K renewal and registration submissions, UDI project, and EUDAMED registration with EU MDR for the organization
- Accounted for all responses for 483, warning letters, or consent decrees to international agencies and FDA and initiated processes to satisfy findings during inspections
- Impacted organizational change with $14M savings in remediation through improvement opportunity identification
- Served internally as Head of CAPA Center of Excellence and Head of Privacy and security for Global Quality.
Global Head
01.2017 - 01.2018
- Population Health Management ad interim, Recruited into role to identify and resolve regulatory and third-party inspections and audits of business unit quality systems while effectively maintaining and enhancing market standing
- Strategized and developed team structure through talent acquisition for Q&R functioning
- Spearheaded company restructuring to improve operational quality for population health management by overhauling healthcare internal audit functionality
- Initiated quality compliance programs focused on design controls, regulatory compliance, and software validation
- Executed strategies for $800M telehealth solutions and outreach business unit with new business model, budgets, and growth for Q&R taking the company from product to solution offerings
- Generated more FDA regulatory clearances by improving time-to-market procedures with multiple business segments
- Supported company vision serving internally as Q&R Head of Connected Devices, Propositions, and Platforms tasked with performing compliance and audit functions successfully.
Regional Director
Johnson & Johnson
01.2009 - 01.2016
- Led best practice strategy implementation to align with company objectives, ensure lean maturity, and comply with federal regulations for North American distribution centers
- Adjusted policies and processes to adhere with current and changing regulations on quality management systems
- Contributed to decisions which improved internal controls with multiple agencies through providing organizational regulatory compliance guidance
- Aligned with organizational vision through creating and launching regional quality management programs, which impacted supplier quality, transportation, customer experience, and vendor selection
- Streamlined policies and procedures ensuring regulatory compliance and established metrics regionally to track performance, effectiveness, and promote continuous process improvement
- Analyzed, acquired, and integrated two companies with seamless infrastructure, operations, cGxP compliance, and finance integrations
- Innovated reduced expenses totaling more than $50M global budget initiatives internationally with streamlined processes and identifying resource capacity with process improvement practices.
Education
Master of Business Administration (M.B.A - Healthcare Business & Policy
Saint Joseph’s University/Mayes College of Pharmaceutical & Healthcare Business
Bachelor of Arts (B.A - Communications
Ramapo College of New Jersey
Skills
Operational improvements
undefinedAffiliations
Member: American Red Cross, The BioIndustry Association (BIA), Drug Information Association (DIA)
Board Development and Strategic Planning Committee, Board of Directors: Central Bucks Family YMCA
3rd Degree Knight: Knights of Columbus
McIlhinney / Division 3 Member: Ancient Order of Hibernians in America
Additional Information
- Honors & Awards , Presidential Leadership Award: Johnson & Johnson
Timeline
RA Project Leader
Johnson & Johnson/Depuy Synthes, Global UDI and EU EUDAMED
06.2023 - Current
Senior Director
GE HealthCare
01.2023 - 06.2023
Global Head
SmithKline Beecham
01.2018 - 01.2021
Global Head
01.2017 - 01.2018
Regional Director
Johnson & Johnson
01.2009 - 01.2016
Head of Quality Transformation
Royal Phillips
Director, Chief Information Officer
Johnson & Johnson
Assistant Director
GlaxoSmithKline
Regional Manager
Merck & Company
Master of Business Administration (M.B.A - Healthcare Business & Policy
Saint Joseph’s University/Mayes College of Pharmaceutical & Healthcare Business
Bachelor of Arts (B.A - Communications
Ramapo College of New Jersey
Similar Profiles
Suzanne BridgesSuzanne Bridges
Paralegal/Office Supervisor at Phillips, Carson & PhillipsParalegal/Office Supervisor at Phillips, Carson & Phillips
Kelly CokerKelly Coker
Executive Director at Phillips University, Inc. (PU) and Phillips University Legacy Foundation (PULF)Executive Director at Phillips University, Inc. (PU) and Phillips University Legacy Foundation (PULF)
Madison ArnoldMadison Arnold
Skills Coach at L.E Phillips Career Development CenterSkills Coach at L.E Phillips Career Development Center
Kelly CookKelly Cook
Drive Up and Go at Acme Fresh MarketDrive Up and Go at Acme Fresh Market
Joseph PizziJoseph Pizzi
Pilot at American AirlinesPilot at American Airlines