Associate Director, Pharmacovigilance Quality Assurance
Vertex Pharmaceuticals is seeking an Associate Director of Pharmacovigilance (PV) Quality to join our Quality Compliance Management team in Cambridge, MA.
The Associate Director of PV Quality Compliance Management is responsible for managing Quality Assurance program and interacting with professionals responsible for overseeing internal and external global PV activities related to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPVP), GMP, industry standards and regulations. Although this role is primarily an individual contributor, this individual may also share responsibility for technical development of team members and ensuring the quality of deliverables within their purview.
- Demonstrates the ability to successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for advancement of all goals and objectives.
- Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GPVP regulated activities
- Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process
- Displays highly developed organizational leadership qualities
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GPVP, and quality systems and management.
- Helps craft department goals and ensures linkage to individual goals
- Displays highly effective coaching abilities as well as a successful track record of developing junior staff
- Conduct presentations on quality issues, initiatives and projects at cross functional meetings
- Ensures appropriate systems are in place for monitoring global procedures and practices
- Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.
- Development, implementation, and oversight of quality activities in support of GPVP activities conducted or monitored by Vertex Pharmaceuticals Inc. These activities include qualification and monitoring of GPVP Service Providers, monitoring internal GPVP quality systems, supporting regulatory inspections, performing duties required of an internal Quality Assurance Unit, and building cross-functional agreements on strategic quality initiatives.
- Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements.
- Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests.
- Master’s degree in a scientific or allied health field and 7+ years of global GPVP work experience, or
- Bachelor’s Degree in a scientific or allied health field and 10+ years of GPVP work experience,
- 5+ years’ experience serving in a senior Quality Management role
- Ability to travel 25%
- Managerial experience in planning, budgeting, and personnel development is required.
- Demonstrated leadership skills are critical to this role.
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Powerpoint)
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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