Project/Program Lead
About Candidate
Introduction:
A seasoned professional with 38 years of experience in the pharmaceutical, biotech, and medical device industries, leading global development programs from inception to successful product launches. Expertise in project and program leadership, quality assurance, regulatory compliance, and business development. Managed cross-functional teams across multiple disciplines, ensuring compliance with cGMP, ISO 13485, and CFR 820 standards. Led Chemistry, Manufacturing, and Controls (CMC) projects, overseeing CDMO collaborations and clinical trial approvals in the EU and the USA. Directed life cycle management for drug delivery systems, formulation enhancements, and medical device development. Spearheaded business expansion strategies, securing major licensing and supply contracts with top pharmaceutical companies. Proficient in risk management, strategic planning, and execution of large-scale projects. Established and optimized project management tools and quality systems to enhance operational efficiency. A results-driven leader with a track record of driving innovation, revenue growth, and regulatory excellence.
Responsibilities:
- Led global development programs, ensuring compliance with regulatory and quality standards.
- Managed cross-functional teams, including engineering, operations, compliance, and customer service.
- Oversaw Chemistry, Manufacturing, and Controls (CMC) projects, ensuring product development milestones were met.
- Directed life cycle management strategies for drug delivery systems and medical devices.
- Established and maintained quality assurance processes in compliance with cGMP, ISO 13485, and CFR 820.
- Developed business strategies, securing major licensing and supply contracts with leading pharmaceutical firms.
- Implemented risk management frameworks, ensuring smooth execution of complex projects.
- Spearheaded market expansion initiatives, driving revenue growth and operational efficiency.
- Led strategic business development efforts, including client relationship management and service expansion.
- Developed and launched innovative drug delivery systems, including electronic auto-injectors and combination products.
- Conducted market research and analysis to identify growth opportunities and improve business performance.
- Implemented project management tools and methodologies to enhance productivity and efficiency.