Executive Director, Quality (GxP)
Description
Our client is an innovative Biotech company working on cutting-edge Oncology therapies across multiple indications and they are led by industry veterans with a rich tradition of drug approval/launch.
This position will report directly to the CEO and have the opportunity to manage the Quality group across strategy and design, cross-functional management, direct reports, executive-level interaction, etc. Given the culture and environment within Biotech, our client is looking for a seasoned and dynamic Quality professional that can bring GxP strategic expertise and strong leadership skills, while also remaining hands-on and eager to drive a highly-functioning department.
Location
Central New Jersey
Responsibilities
- Responsible for directing, coordinating, creating and evaluating the activities of the Quality Department across Manufacturing (GMP), Clinical Development/Operations (GCP) and Laboratory (GLP).
- Development, implementation and monitoring of Quality programs and policies to ensure that the Company’s drug development activities are in compliance with Corporate policy, US Food and Drug Administration regulations and those of other applicable regulatory bodies.
- Monitoring of the external regulatory environment and making recommendations as appropriate to senior management on potential strategic issues that may impact the Company.
- Lead and direct Quality staff responsible across programs and systems.
- Review, approve and/or create all relevant documents including SOP’s, policies, investigations, audits, etc.
- Strategic oversight of internal audits, vendor audits/qualifications, corrective/preventive action recommendations, etc.
- Develop and implement departmental budgets, timelines and resources.
- Establish and execute corporate Quality Compliance policy and regulatory compliance strategies, and ensure GMP, GLP and GCP compliance at all sites and suppliers.
- Strategize and collaborate with other departments to ensure timely completion of all objectives and milestones, including Manufacturing, Supply Chain, Product Development, Regulatory Affairs, Clinical Development/Operations, Laboratory Operations, etc.
- Improve, create and implement Quality Systems, Manuals, etc.
- Develop a risk assessment strategy aligning with corporate risk management strategy ensuring timely, effective, and consistent execution of the risk strategy, including mitigating risk.
- Oversight/leadership for issues/risks/trends/process improvement opportunities and ensure that they are appropriately communicated internally.
- Ensure that appropriate quality and compliance metrics are in place, are being measured, and are being consistently tracked and reported on.
- Provides quarterly reports for management review on the status of compliance, and quality standards of all facilities, processes, procedures and practices.
- Accountable for leadership, strategic oversight and expert input on all quality and compliance issues arising on clinical studies and ensures appropriate corrective and preventative action plans are defined and implemented.
- Establish and maintain GMP/GLP/GCP training.
- Lead inspection activities as well as any inspection readiness-related activities.
Qualifications / Requirements
- An advanced degree is required.
- 20+ years of leadership experience within Pharma and/or Biotech, specifically within Quality.
- Biologics experience is required.
- Direct report/people management is required.
- Must have a strong understanding across GMP and GCP, with further experience within GLP being desirable.
Contact
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