Corina Posey
Canal Winchester,OH
Summary
A highly skilled servant-style leader with a background in strategic planning, team leadership, and project management. Strengths lie in communication, problem-solving, and negotiation skills that foster strong relationships and drive operational success. Leverages a tenacious approach and strong attention to detail. Service-oriented and performance-driven, with excellent organizational, multitasking, and problem-solving skills. Previous work has resulted in streamlined processes, improved productivity, and enhanced employee engagement.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Associate Director Global Quality Systems-Compliance
Vertex Pharmaceuticals
Boston, USA
10.2021 - Current
- Developed and implemented strategies necessary for minimizing risk of non-compliance.
- Established internal controls and processes to support compliance through project management and engagement of key stakeholders.
- Created and managed action plans to mitigate audit discoveries and compliance concerns.
- Implemented compliance technology systems to track and monitor compliance with global, federal, and state level regulatory requirements and internal policies.
Director – Regulatory Affairs & Quality
Covetrus North America
Dublin, OH
04.2019 - 10.2021
- Developed and implemented comprehensive strategies to improve operational processes and organizational efficiency.
- Spearheaded development of QMS containing 8 modules including complaints, CAPAs, change control, supplier qualifications, inspections, audits, training, and document control
- Conducted in-depth analyses of controlled substance drug order trends, resulting in a 30% reduction in the submission reporting of investigations to federal and state regulatory authorities
- Created detailed plans outlining timelines, goals, budgets, staffing needs, and other requirements for projects.
Regulatory Labeling & Compliance Manager
Vertex Pharmaceuticals
Boston, USA
08.2016 - 04.2021
- Supported strategic development and objective setting by analyzing audit outcomes and generating actionable recommendations.
- Effectively managed National Accredited Board of Pharmacy (NABP) accreditations and maintained over 630 State and DEA licenses for 14 distribution centers and the corporate office, ensuring no loss of licensure.
- Collaborated with department leads to develop a new brand strategy, and revised policies, procedures, and work instructions; successfully bringing the current portfolio of over 1,000 products into compliance.
Education
MBA - Health Administration
Keller Graduate School of Business
04-2016
BBA - Technical Management
DeVry University
Downers Grove, IL04-2011
Skills
- People Management
- Rules and regulations
- Cross-functional team leadership
- Verbal and written communication
- Strategic Planning
- Staff Development
- Project Management
- Negotiation
- Legal and Regulatory Compliance
Certification
- Certified Associate Project Management
- Regulatory Affairs Certification (In progress)
References
References available upon request.
Timeline
Associate Director Global Quality Systems-Compliance
Vertex Pharmaceuticals
10.2021 - Current
Director – Regulatory Affairs & Quality
Covetrus North America
04.2019 - 10.2021
Regulatory Labeling & Compliance Manager
Vertex Pharmaceuticals
08.2016 - 04.2021
MBA - Health Administration
Keller Graduate School of Business
BBA - Technical Management
DeVry University
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