- technical and
business education
-
expertise
in global manufacturing, quality
assurance, regulatory affairs
and compliance
-
technical
expertise in pharmaceuticals, dietary supplements,
dosage
forms and APIs, medical devices and
diagnostic products and cosmetics
-
strong
written and verbal communication skills
-
commitment to industry demonstrated through organizational
and government regulatory contributions
-
numerous presentations, publications and patents
KEY
SUCCESS FACTORS
¨
Technical
expertise as well as the necessary access to the FDA to
implement successful audits and inspections, through full
compliance, and approvals for product application regulatory
approvals, ie, ANDAs/NDAs, DMFs.
¨
Lead global
manufacturing and corporate initiatives. Provide uniform
operations in plants for product registrations worldwide, thus
ensuring higher levels of compliance and reduced costs.
Organizing teams and establishing and implementing systems which
produce results, as evidenced by successful company integrations
from merger/acquisition activities.
¨
Management of
multinational, multiplant operations to achieve corporate goals
and global regulatory compliance – manufacturing, quality
assurance and regulatory affairs and compliance. Achieve
worldwide product registrations and GMP compliance.
¨
Integrate the
manufacturing and quality operations in a multinational
organization into uniform and consistent quality standards and
systems.
¨
Participation in a
growing organization, to utilize my technical and business
background and expertise toward developing the company's
business and ability to supply quality products.
