Summary
Overview
Work History
Education
Skills
Affiliations
Highlightsofachievements
Certification
Languages
Timeline
Joseph Brennan

Joseph Brennan

Doylestown

Summary

An efficiency and effectiveness champion with 20+ years of progressive experience in implementing tactical strategic initiatives with strong resource controls and vision. Results-driven visionary leadership in business start-ups, turn-arounds, and operational management of multi-site, national, and international operations.Dynamic individual with hands-on experience in Pharmaceuticals, Biotechnology, Medical Devices and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.

Overview

33
33
years of professional experience
1
1
Certification

Work History

Global Head, Quality & Regulatory, Compliance and Audit

Royal Philips
01.2016 - Current
  • Company Overview: Global leader in health technology, improving people's lives through meaningful innovation
  • As Philips’ Risk Officer, lead and oversee annual risk assessment process and identify controls in place to mitigate identified risks
  • Create, implement, and deploy an annual audit plan and schedule
  • Develop and Drive Internal Audit strategy for Philips
  • Lead and oversee Internal Audit's planning, testing, and validation of internal controls
  • Responsible for final work to ensure observations/findings are adequately supported and documented in accordance with regulatory requirements and company standards; ensuring adequacy and completeness of audits performed
  • Manage and direct 37 staff members and over 400 members of Philips’ audit pool
  • Oversee professional development and maturation of the staff and harmonization of all internal audit programs including clinical
  • Support external audits as necessary
  • Lead and oversee Mergers and Acquisitions function for Quality and Regulatory workstreams
  • Head of CAPA Center of Excellence
  • Head of Privacy & Security for Global Quality
  • Global leader in health technology, improving people's lives through meaningful innovation

Global Head, Quality & Compliance, Population Health Management

Royal Philips
01.2016 - Current
  • Company Overview: Global leader in health technology, improving people's lives through meaningful innovation
  • While performing in Compliance & Audit function, as well as serving as Q&R Head of Connected Devices, Propositions and Platforms, Led a team developing and implementing quality systems, compliance, and regulatory strategies for a $800M telehealth solutions and customized outreach business
  • Enhanced time to market and engaged entrepreneurial spirit within the PHM business units increasing FDA regulatory clearances
  • Defended regulatory and third body inspections/audits of business unit quality systems, e.g
  • U.S
  • Food & Drug Administration (FDA) inspections and European Union (EU) Notified Body audits, maintaining and enhancing market standing
  • Contributed to the business group corporate quality compliance and excellence programs
  • Subject Matter Expert on design controls, regulatory compliance, and software validation
  • Developed team structure and talent acquisition for quality and regulatory functions positioning the organization for success
  • Led preparation of Technical Files for new products and technologies for CE marking
  • Promoted continuous quality improvement within team objectives
  • Devised Q&R strategy and budgets to accelerate PHM’s evolution from product offerings to solutions offerings
  • Global leader in health technology, improving people's lives through meaningful innovation

Regional Director, Quality Execution & Projects, Global Distribution

Johnson & Johnson
01.2005 - 01.2016
  • Company Overview: A global leader in consumer health, pharmaceuticals, and medical devices
  • Responsible for Operations project delivery and oversight of Quality Management Systems and Regulatory Compliance at J&J Distribution Centers and Transportation within the United States and Canada that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors
  • Ensured LEAN maturity and adherence at all North American Distribution Centers
  • Implemented a Regional Supplier Quality Management Program which includes vendor selection, management, and disengagement
  • Devised and deployed a Regional Quality Management System for North America for Transportation, Customer Service, and Supplier Quality
  • Improved critical metrics across the region, streamlining processes, and improving overall regulatory compliance at all logistics centers
  • Ensure compliance with current and emerging regulations and the impact to quality and distribution practices such as FDA, DEA, TSA, DOT, and Standards organizations such as ISO and Notified bodies such as BSI, TUV etc
  • Execute and maintain quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations
  • Provide regulatory compliance guidance and accountable for decision making for J&J Distribution North America in order to be fully compliant with government and corporate requirements in all states where Distribution Centers operate
  • Provide escalation communication and coordination with Sector and Franchise quality organization reporting to regulatory agencies including US FDA Investigators, ISO-13485:2003 auditors, and J&J Regulatory Compliance
  • Leaned out processes for Repack/Relabel, Product Returns processes in Canada and the U.S
  • A global leader in consumer health, pharmaceuticals, and medical devices

Director, Medical Knowledge Management

Johnson & Johnson
01.2005 - 01.2016
  • Company Overview: A global leader in consumer health, pharmaceuticals, and medical devices
  • Part of Leadership Team responsible for clinical program management teams and deliverables
  • Outsourced key clinical trial activities to U.S
  • And Asia-based CROs, driving supplier selection, audit, and contract negotiation, ensuring compliance with J&J and FDA policies and regulations as well as driving cost savings in excess of $60MM per year in clinical trial costs by LEANing out medical writing processes and gathering of physician feedback on clinical submissions through Kaizen workshops
  • A global leader in consumer health, pharmaceuticals, and medical devices

Director, Global Process Improvement

Johnson & Johnson
01.2005 - 01.2016
  • Company Overview: A global leader in consumer health, pharmaceuticals, and medical devices
  • Responsible for the development and implementation of the IT and Automation Global Operations process and solutions to support the organization's project portfolio and compliance operations environment
  • Responsible for ensuring service level targets are met across the enterprise
  • Member of the global team responsible for implementation of ITIL processes and accompanying system that is used by service personnel and executive leadership of all Johnson and Johnson companies worldwide
  • A global leader in consumer health, pharmaceuticals, and medical devices

Director, Worldwide IT Operations, Medical Devices, and Diagnostics

Johnson & Johnson
01.2005 - 01.2016
  • Company Overview: A global leader in consumer health, pharmaceuticals, and medical devices
  • Led LEAN process development and improvement initiatives, encompassing training and change management for Rochester Manufacturing and Clinical Operations through series of Kaizen workshops
  • A global leader in consumer health, pharmaceuticals, and medical devices

Chief Information Officer

BioClinica
01.2003 - 01.2005
  • Company Overview: A leading provider of imaging and cardiac services for clinical trials
  • Managed international team of five direct and 15 indirect reports, responsibility included all facets of IT, Operations, and Quality Assurance functions
  • Built an IT function to support global clinical trials for Princeton Radiology Pharmaceutical Research
  • A leading provider of imaging and cardiac services for clinical trials

Assistant Director, Biopharmaceutical Development

GlaxoSmithKline
01.1992 - 01.2003
  • Company Overview: A global healthcare company that researches and develops a broad range of innovative medicines and brands
  • Lead seamless integration of IT and MA staff and systems in merger of Glaxo Wellcome and Smithkline Beecham
  • A global healthcare company that researches and develops a broad range of innovative medicines and brands

Regional Manager for Europe, Middle East, and Africa

Merck & Company
01.1992 - 01.2003
  • Company Overview: A global healthcare company that delivers innovative health solutions through its prescription medicines, vaccines, biologic therapies, and animal health products
  • MA and IT Manager of 14 international teams of more than 150 staffers at various Merck facilities in eight countries
  • A global healthcare company that delivers innovative health solutions through its prescription medicines, vaccines, biologic therapies, and animal health products

Manager, Regional Command Center Director of Operations

CitiGroup
01.1992 - 01.2003
  • Company Overview: A global financial services company that provides consumers, corporations, governments, and institutions with a broad range of financial products and services
  • A global financial services company that provides consumers, corporations, governments, and institutions with a broad range of financial products and services

Systems Engineer

IBM Corporation
01.1992 - 01.2003
  • Company Overview: An American multinational technology company that provides hardware, software, cloud-based services, and cognitive computing
  • Provided customer support to IBM, Pepsi Co., and American Express driving customer satisfaction levels to all-time highs
  • An American multinational technology company that provides hardware, software, cloud-based services, and cognitive computing

Education

MBA - Pharmaceutical Business and Healthcare Policy

Mayes College of Pharmaceutical and Healthcare Business, Philadelphia, PA

Bachelor of Arts - Communications

Ramapo College of New Jersey, Mahwah, NJ

Skills

  • General/Operations Management
  • Strategic Planning and Execution
  • Process Redesign and Improvement
  • Mergers and Acquisitions
  • CRO Selection/Audit
  • Profit and Loss Management
  • Sales and Profit Growth
  • Team Building and Leadership
  • Change Management
  • Legal, Financial, & IT Compliance
  • Friendly, positive attitude
  • Teamwork and collaboration
  • Problem-solving
  • Flexible and adaptable
  • Excellent communication
  • Critical thinking
  • Calm under pressure
  • Organization and time management
  • Problem resolution

Affiliations

  • Drug Information Association
  • Central Bucks Family YMCA
  • Member, Board of Directors
  • Member, Board Development Committee
  • Member, Strategic Planning Committee
  • Knights of Columbus, Third Degree Knight
  • Ancient Order of Hibernians in America, McIlhinney/Division 3

Highlightsofachievements

  • Key lead in the merger of Glaxo Wellcome and Smithkline Beecham, selecting processes, systems, and personnel needed for day 1 of the newly formed GlaxoSmithkline.
  • Saved Philips Healthcare $14MM in remediation spend.
  • Key lead in the assessment and subsequent acquisition of two companies (Amic and Immunicon) into the family of Johnson and Johnson companies.
  • Conserved Johnson & Johnson more than $50M by proper management of an international team to drive global budget reduction initiatives.
  • Grew RadPharm (BioClinica) start-up revenue from $50M to $95M in less than one year.
  • Transformed Philips Healthcare’s Internal Audit function as well as helped lead Population Health Management through a massive organizational change.

Certification

  • Name of Certification Issuing Organization Year Month
  • Area of certification

Languages

Italian
Elementary

Timeline

Global Head, Quality & Regulatory, Compliance and Audit - Royal Philips
01.2016 - Current
Global Head, Quality & Compliance, Population Health Management - Royal Philips
01.2016 - Current
Regional Director, Quality Execution & Projects, Global Distribution - Johnson & Johnson
01.2005 - 01.2016
Director, Medical Knowledge Management - Johnson & Johnson
01.2005 - 01.2016
Director, Global Process Improvement - Johnson & Johnson
01.2005 - 01.2016
Director, Worldwide IT Operations, Medical Devices, and Diagnostics - Johnson & Johnson
01.2005 - 01.2016
Chief Information Officer - BioClinica
01.2003 - 01.2005
Assistant Director, Biopharmaceutical Development - GlaxoSmithKline
01.1992 - 01.2003
Regional Manager for Europe, Middle East, and Africa - Merck & Company
01.1992 - 01.2003
Manager, Regional Command Center Director of Operations - CitiGroup
01.1992 - 01.2003
Systems Engineer - IBM Corporation
01.1992 - 01.2003
Mayes College of Pharmaceutical and Healthcare Business - MBA, Pharmaceutical Business and Healthcare Policy
Ramapo College of New Jersey - Bachelor of Arts, Communications

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Joseph Brennan