ANGELIKI KIKI ESPOSITO
Broomall,Pennsylvania
Summary
Accomplished pharmaceutical industry leader with 20+ years of cross-sector experience in R&D, supply chain, quality, and regulatory disciplines. Recognized for leading global teams, executing complex integrations, and driving quality excellence across the product lifecycle. Brings a collaborative, inclusive, and results-oriented approach to strategic transformation.
Overview
28
28
years of professional experience
1
1
Certification
Work History
Director, Product Quality Management - Small Molecule Launch and Grow
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2019 - Current
- - Led product quality for successful $1B+ Intra-Cellular acquisition and 4 additional deals.
- - Directed PQ initiatives for small molecule products across internal and external sites.
- - Acted as NA SME for L&A due diligence across small and large molecule assets.
- - Built and led the first PQM Culture team; appointed NA Lead for Mental Health Diplomats.
Director, RA Acquisitions and Divestitures
Johnson & Johnson Regulatory Operations
01.2018 - 01.2019
- - Standardized regulatory plans for multi-region divestitures (EMEA, APAC, NA).
Labeling Project Lead
Johnson & Johnson Regulatory Operations
01.2016 - 01.2018
- - Defined future-state end-to-end labeling processes for external partnerships.
Director, Labeling Regulatory Ops
J&J Consumer
01.2015 - 01.2016
- Led inspection response; won Encore Award.
Associate Director
McNeil
01.2012 - 01.2015
- Led FDA consent decree commitments, raised cycle adherence 56%->90%.
QA/Aseptic Mgr
J&J
01.2007 - 01.2012
- Directed global aseptic QA, successful PAI outcomes.
Project Mgr
Barry-Wehmiller
01.2006 - 01.2007
- Led launch of new molecular entities; earned 3 performance awards.
Validation Engineer
Centocor & SmithKline
01.1998 - 01.2004
- Supported global tech transfers; zero FDA 483s.
Education
M.S. - Engineering Management
Drexel University
01.2010
B.S. - Biological Sciences
Drexel University
01.1999
Skills
- Pharmaceutical Quality Management Regulatory Operations M&A Due Diligence Cross-Functional Leadership FDA Inspection Readiness Strategic Process Improvement Change Management Global Supply Chain Quality Labeling Compliance
Websites
Certification
- - Quality Engineer Certification
- - Flawless Project Execution Training
- - Six Sigma Training
- - Agile Methodologies
- - Sterile Process Leadership Program
- - Culture Carriers Change Management Leadership Program
Languages & Volunteer Experience
- Fluent in Greek
Timeline
Director, Product Quality Management - Small Molecule Launch and Grow
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2019 - Current
Director, RA Acquisitions and Divestitures
Johnson & Johnson Regulatory Operations
01.2018 - 01.2019
Labeling Project Lead
Johnson & Johnson Regulatory Operations
01.2016 - 01.2018
Director, Labeling Regulatory Ops
J&J Consumer
01.2015 - 01.2016
Associate Director
McNeil
01.2012 - 01.2015
QA/Aseptic Mgr
J&J
01.2007 - 01.2012
Project Mgr
Barry-Wehmiller
01.2006 - 01.2007
Validation Engineer
Centocor & SmithKline
01.1998 - 01.2004
M.S. - Engineering Management
Drexel University
B.S. - Biological Sciences
Drexel University