T. David Hansen
Sellersville,PA
Summary
Regulatory Compliance professional with Thirty Five years of experience in Pharmaceutical, Biopharmaceutical, Vaccine and Sterile Quality Operations. Knowledgeable in quality assurance disciplines (internal/external auditing, cGMP, Aseptic, EU and ICH guidelines, CRF including the 820's), associated with pharmaceutical, biological and sterile manufacturing/filling facilities. Competencies include cGMP compliance expertise, proactive risk identification and mitigation, development of site specific Quality Culture programs, Health Authority inspection preparation and support, facility design and licensing, recall coordination, Field Alert reporting, systems based auditing, environmental monitoring, and effective project and people management, oral communications, and organizational and facilitative skills as well as budget maintenance and profit planning experience.
Overview
21
21
years of professional experience
1
1
Certification
Work History
External Quality Large Molecule Lead Americas
Johnson & Johnson
Horsham, PA
05.2022 - 12.2022
- Lead a team of 10 to Assure Quality and Compliance programs are implemented and maintained while proactively identifying and prioritizing compliance risks.
- Manage escalation and resolution of Quality and Compliance issues
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Worked closely with organizational and external leadership to guide operational strategy.
- Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
External Quality Hypercare Lead
Johnson & Johnson
Horsham, PA
01.2022 - 05.2022
- Responsible for leading Quality Assurance and Compliance oversight for high risk external manufacturing sites requiring "hypercare" support ensuring implementation and execution of enhanced quality oversight models based on key risk drivers to ensure reliable and compliant product supply.
- Collaborated with cross-functional teams to address root causes of quality issues, resulting in improved processes and products.
- Reduced customer complaints by identifying areas for improvement and initiating corrective actions.
- Developed quality policies, procedures, and work instructions tailored to specific needs of organization.
- Communicated effectively with customers regarding their concerns or inquiries related to product quality or safety.
Director J&J Regulatory Compliance
Johnson & Johnson
Horsham, PA
10.2012 - 12.2021
- Provide leadership for deployment and maintenance of strategic regulatory and quality requirements within Janssen internal and external sites and assure compliance programs are implemented and maintained
- Work with business partners to mitigate compliance risk at responsible manufacturing sites and assist those sites in preparing for and management of Pre-Approval and routine Health Authority inspections
- Proactively identify, prioritize, communicate, and develop mitigation for compliance risks at sites and partner with compliance peers within group and within Enterprise, as appropriate, for consistency and leveraging opportunities
- Manage escalations and provide innovative resolution for quality and compliance issues
- Lead Quality Culture Workstream for Janssen with an emphasis on influencing proactive quality to enable business growth.
Senior Manager Global Compliance
Johnson & Johnson
Horsham, PA
12.2010 - 10.2012
- Provided Global Compliance support to internal and external Manufacturing sites.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- This support includes providing compliance guidance on escalations, Health Authority inspections, recall activities, and communications with Health Authorities. Coordinate all logistics associated with Recall Committee, as well as being the primary point of contact for communications with Health Authorities.
- Graduated from the Johnson and Johnson Rising Leader Program and was appointed to the extended leadership team for Janssen Supply Chain Quality and supported the development of objectives and strategies for the JSC Quality organization.
Manager Global Compliance
Johnson & Johnson
01.2009 - 12.2010
- Provide Global compliance support to Vacaville and external manufacturers. This support included providing compliance guidance on escalations, Health authority inspections, and recall activities
- Recall coordinator for the Procrit recall. This included coordinating all aspects of the recall package development, approval, and submission to FDA
Manager Global Compliance Auditing
Johnson & Johnson
Horsham, PA
06.2006 - 01.2009
- Supervised 3 reports to manage the Janssen audit program for both domestic and international contract labs, suppliers, Janssen sites, and contract manufacturing sites
- Developed and maintained relationships with customers and suppliers through account development.
- Developed and maintaining procedures and schedules in accordance with Health Authority regulations
- Developed the training requirements and coordinated training for three direct reports and site personnel as required
- Reviewed all audit reports and elevated critical issues in accordance with CAPA and management escalation procedures.
- Self-motivated, with a strong sense of personal responsibility.
Sr. Manager Quality Assurance Product Disposition
Johnson & Johnson
Malvern, PA
01.2006 - 06.2006
- Supervised 7 reports to manage the Batch Record Review and QA Product Disposition activities for the Malvern site to assure the accurate and timely release of PFB
- Provided strong leadership to enhance team productivity and morale.
Sr. Manager Quality Assurance
Centocor
Malvern, PA
12.2003 - 12.2005
- Supervised 3 employees and managed activities related to QA Compliance and Quality Systems, to support GBSC Manufacturing at Malvern
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
- Assisted in assuring Malvern was in full compliance with regulatory, industry, J&J and Centocor requirements
- Planned and coordinated internal and external audits and coordinated logistics associated with regulatory visits
- Established the inspection readiness programs to ensure that the quality systems supporting the manufacturing facility maintain a state of inspection readiness
- Developed a system for the inspection readiness process
- Process excellence tools including VOC, SIPOC and Process Mapping were used to develop this procedure
- The outcome was the development of an inspection readiness manual that provides current information surrounding the logistics of the preparation process, the logistics surrounding the conduct of the inspection as well as the procedures for responsibilities following the inspection
- This manual clearly defines roles and responsibilities.
GMP Compliance Franchise Leader
Merck & Co.
Westpoint, PA
07.2001 - 11.2003
- Responsible for various quality assurance activities with primary focus on Live Virus Vaccine, media preparation, and glassware/equipment sterilization facilities to assure both domestic and international inspection readiness
- Increased team productivity by streamlining communication and implementing effective project management strategies.
- Identified team weak points and implemented corrective actions to resolve concerns.
Education
Master of Science - Biology
Villanova University
Villanova, PA05.1989
Bachelor of Science - Biology
Ursinus College
Collegeville, PA05.1986
Skills
- Regulatory Compliance
- Issues Resolution
- Strategic Planning
- Relationship Building
- Effective leader
- Quality Assurance
Certification
- Rising Leader Program Graduate
- EXLT member
- Decision Support leader for Janssen Quality
- Green Belt Certified
Hobbies and Interests
- Golf
- Skiing
- Scuba Diving
- Fishing
- Fantasy Football
Timeline
External Quality Large Molecule Lead Americas
Johnson & Johnson
05.2022 - 12.2022
External Quality Hypercare Lead
Johnson & Johnson
01.2022 - 05.2022
Director J&J Regulatory Compliance
Johnson & Johnson
10.2012 - 12.2021
Senior Manager Global Compliance
Johnson & Johnson
12.2010 - 10.2012
Manager Global Compliance
Johnson & Johnson
01.2009 - 12.2010
Manager Global Compliance Auditing
Johnson & Johnson
06.2006 - 01.2009
Sr. Manager Quality Assurance Product Disposition
Johnson & Johnson
01.2006 - 06.2006
Sr. Manager Quality Assurance
Centocor
12.2003 - 12.2005
GMP Compliance Franchise Leader
Merck & Co.
07.2001 - 11.2003
Master of Science - Biology
Villanova University
Bachelor of Science - Biology
Ursinus College