Associate Director, Quality Compliance Management (Clinical & Non-Clinical) Job in Cambridge 02139, Massachusetts Us
The Associate Director of Quality Compliance Management is responsible for managing a team of Quality Assurance professionals responsible for overseeing non-clinical and clinical activities related to GCP, GLP, and Pharmacovigilance (PV) industry standards and regulations. This role is also responsible for technical development of personnel and ensuring the quality of deliverables within their purview.
Key Responsibilities
-Demonstrates broad and deep expertise related to understanding the principles and application of quality and regulatory compliance related to GCP, PV, and GLP 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 GCP, PV, and GLP 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
-Participates in activities to set strategic direction of Global Patient Safety
-Conduct presentations on quality issues, initiatives and projects at cross functional meetings
-Approves work related travel and expense reports for members of their functional group
-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 GCP, PV, and GLP activities conducted or monitored by Vertex Pharmaceuticals Inc. These activities include, but are not limited to the following: Qualification and Monitoring of GCP, PC, and GLP Service Providers, Staff Training and Mentoring, Deviation Investigation Review, Ad-hoc Report and submission audits, Audit/Inspection Support, GLP Quality Assurance Unit Requirements per 21 CFR part 58, and .
-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.
-Development and reporting of compliance metrics related to GCP, PV, and GLP activities
-Coaches/mentors staff as a means to ensure performance and professional development
-Establishes/maintains effective cross functional team communications to advance quality activities of Vertex.
-This position requires up to 10% travel.
Qualifications
-M.S. in a scientific or allied health field and 7+ years of GCP, PV, and GLP work experience, or
-B.S. in a scientific or allied health field and 10+ years of GCP, PV, and GLP work experience,
-5+ years experience serving in a senior Quality Management role.
-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, 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 U.S., U.K. and Canada. Vertex has continually 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 http://www.vrtx.com
VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law. 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.
