Quality Lead, GCP and GPVP Auditing Job in Cambridge 02139, Massachusetts US
ertex Pharmaceuticals is seeking a Quality Lead- GCP/PV Auditing to join our Quality Compliance Management team in Cambridge MA.
The Quality Lead of Quality Compliance Management is responsible for overseeing non-clinical and clinical activities related to GCP and GPVP industry standards and regulations. The Quality Lead is responsible for assisting with the strategic alignment of group or team goals with projects and activities and refining those projects and/or activities proactively.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
- Demonstrates the ability to successfully plan, adjust, manage and optimize all resources for advancement of all goals and objectives.
- Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GCP and GPVP regulated activities
- Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrates ability to effectively communicate and influence the outcomes of the decision making process
- Proven ability to manage projects while meeting all deliverables and timelines
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GCP and GPVP quality systems and management.
- Conduct presentations on quality issues, initiatives and projects at cross functional meetings
- Fosters the demonstration of the Vertex Core Values and leadership behaviors in others.
- Performs other duties as assigned
KEY RESPONSIBILITIES:
- Development, implementation, and oversight of quality activities in support of GCP and GPVP activities conducted or monitored by Vertex Pharmaceuticals Inc. These activities focus around the qualification and monitoring of GCP and GPVP Service Providers.
- 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.
- Establishes/maintains effective cross functional team communications to advance quality activities of Vertex.
- This position requires up to 30% travel.
Minimum Qualifications:
- Master's degree in a scientific or allied health field and 3+ years of GCP and GPVP work experience, or
- Bachelor's degree in a scientific or allied health field and 6+ years of GCP and GPVP work experience
- 3+ years experience serving in a Quality role
- Ability to travel 30%
Preferred Qualifications
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Powerpoint)
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Demonstrated Leadership skills are critical to this role
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, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, 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, and most recently was named the top employer in Science magazine's 2011 annual survey.
VERTEX is an Equal Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status or any other status protected by applicable law.
