Executive Director, Quality (GxP)

Executive Director, Quality (GxP) Location Greater New York City Area, United States of America Job Type Full-time Description Executive Director, Quality (GxP) | Innovative, Publicly-traded Biotech, Central NJ 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 Thomas J. Fascia Email: tfascia@cornerstonesg.com Phone: 973-656-0220x717 LinkedIn: https://www.linkedin.com/in/thomasfascia Cornerstone Search Group, LLC 1200 Morris Turnpike | Short Hills, New Jersey 07078, USA www.cornerstonesg.com Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission. Back To Featured Searches List Manage Consent To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions. Functional Functional Always active The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network. Preferences Preferences The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Statistics Statistics The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you. Marketing Marketing The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes. Manage options Manage services Manage {vendor_count} vendors Read more about these purposes Accept Deny View preferences Save preferences View preferences {title} {title} {title} Manage Consent To provide the best experiences, we use technologi