Executive Director, Quality Compliance
Confidential
Executive Director, Quality Compliance
About the Company
Innovative pharmaceutical company specializing in oral therapeutics for metabolic & mineral disorders
Industry
Pharmaceuticals
Type
Public Company
Founded
2007
Employees
201-500
Categories
- Pharmaceuticals
- Biotechnology
- Health Care
- Medical Conditions
- Therapeutics
- Medicine
- Manufacturing
- Chemical Products
About the Role
The Company is seeking an Executive Director for Quality Compliance, a senior leader with a strong background in global GxP compliance and quality systems within the biotechnology or pharmaceutical industry. The successful candidate will be responsible for providing independent oversight, assurance, and governance of the company's global GxP compliance framework. This includes leading and developing the Quality Compliance team, establishing and maintaining a risk-based approach to compliance oversight, and being accountable for audits, inspection readiness, quality risk management, and the quality master plan. The role requires a strategic thinker with the ability to set direction, manage resources, and lead through organizational change, as well as a proven track record in building and leading high-performing teams. Applicants for the Executive Director, Quality Compliance position at the company should have a Bachelor's degree in a relevant field, with an advanced degree preferred, and at least 15 years of experience in quality, compliance, or related GxP roles. Significant leadership experience in a commercial-stage organization is essential, as is a strong knowledge of global GxP regulations, including FDA requirements. The role demands a leader with excellent communication, influencing, and executive presence, who can effectively manage quality incidents, and health authority interactions, and provide clear, actionable recommendations to senior leadership. The ideal candidate will have a proven ability to operate within a commercial biopharmaceutical environment and oversee compliance across external partners, and will be adept at translating quality risks and regulatory expectations into strategic quality initiatives.
Hiring Manager Title
SVP, Head of Global Quality
Functions
- Operations
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Job Description Summary Location: Cambridge MA | Internal: Director | LI#-Hybrid This role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (PCS). The team is responsible for handling samples and data associated...- Novartis in Cambridge, MA, seeks a Senior leader to oversee the Study Quality and Compliance team within Preclinical Safety. Manage data, SOPs and archives while driving a software-based tracking and analytics program for study information. The role requires GLP experience...
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Anzu Partners
Waltham, MAa month ago - Monte Rosa Therapeutics seeks a Senior Director/Director Quality GCP to provide strategic oversight of phase-appropriate GCP and GCLP activities, including vendor and investigator site oversight, for active programs. This role requires 75% on-site presence in Boston/Basel...
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