Quality Assurance Lead - GCP
Vertex Pharmaceuticals is looking for a Quality Assurance Lead - GCP to join our Quality Compliance Management team.
The Quality Lead of Quality Compliance Management (QCM) is responsible for conducting the GCP external and internal audit program. This role is also responsible for technical development of personnel and ensuring the quality of deliverables within their purview.
- Demonstrate broad expertise related to the principles and application of GCP quality and regulatory compliance
- Demonstrate strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrate ability to effectively communicate and influence the outcomes of the decision making process
- Display highly developed organizational leadership qualities
- Display highly effective coaching abilities as well as a successful track record of developing junior staff
- Schedule and conduct Good Clinical Practice (GCP) Audits of processes related to clinical and business operations, clinical safety and pharmacovigilance, clinical drug development and pre- and post-marketed drug usage worldwide.
- Conduct GCP audits of Clinical Investigator sites, Vendors, databases, clinical laboratories, systems and processes
- Ensure compliance with company’s procedures and regulatory requirements.
- Deliver audit findings and risk management evaluations at local level to Quality Management, Clinical teams and senior management.
- Obtain and secure Clinical team’s commitment on action plan and follow-up on agreed upon actions.
- Identify opportunities for GCP and business process and internal/external controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with company policies and prevailing government regulations.
- Assess Clinical and business systems and processes to provide Quality management with an evaluation of internal and external controls.
- Provide regulatory expertise and process optimization to customer divisions, clinical teams and conduct field interaction to complement and reinforce QA programs.
- Develop audit reports, coordinate action plans and follow up with auditees to assure prompt and adequate completion of agreed upon actions.
- Contribute in the development of Clinical Research, Safety and Clinical Quality and Compliance systems and standards.
May participate in activities to set strategic direction of Quality Compliance Management
- conduct presentations on quality issues and initiatives at cross functional meetings
- Development, implementation, and oversight of quality activities in support of Quality Compliance Management. These activities include, but are not limited to the following: The GCP Audit Program, GCP Training, Audit/Inspection Support, CAPA review and approval.
- Development and reporting of Quality and compliance metrics related to Quality Compliance Management internal audit activities
- Determine escalation procedures for issues arising from QCM activities and drives process improvement activities
- Coach/mentor staff as a means to ensure performance and professional development
- Establish/maintain effective cross functional team communications to advance quality activities of Vertex
- Master's degree in a scientific or allied health field and 3+ years of GCP and Quality Systems Auditing work experience, or
- Bachelor's degree in a scientific or allied health field and 6+ years of GCP and Quality Systems Auditing work experience
- 3+ years experience serving in a Quality role
- 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
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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