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Job: Quality Officer, Shattuck Labs, Morrisville, NC
Morrisville, NC 27560 United States
Implement, manage, and maintain quality systems to support commercial and development activities for Shattuck Labs. Comply with US and international regulations and standards as they apply to products manufactured in the United Stated and distributed to the US and other countries. Implement a robust Quality Management System (QMS)
o Lead the organization to implement and maintain compliant quality systems.
o Host and organize Management Review meetings on a periodic basis to review the effectiveness of the Quality Management System (QMS).
o Perform lot release activities.
o Provide oversight and management of critical vendors including third party contract manufacturing operations and testing facilities.
o Coordinate and perform vendor qualification and compliance audits.
o Manage the internal audit program.
o Provide oversight for Quality Control activities.
o Develop, manage and maintain a GXP compliant document control system
o Lead and manage the company training program
o Provide quality guidance to product development projects and programs.
o Oversee investigations of non-conformances (NC, Deviation, OOS, CAPA)
o Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the company.
o Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
o Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
o Manage stop shipments, field actions and recall activities
o Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
o Budgetary and managerial responsibility for Quality Assurance
o Represent QA at senior management meetings.
o This position has direct impact on the following systems:
o Document control
o Change management
o Batch record review and lot release
o Management review
o Complaints / MDRs
o Audits (internal & external)
Position may require travel and periodic evening and weekend work, as necessary to meet manufacturing and regulatory deadlines
Qualifications and Requirements?
o Degree (advanced degree preferred) in biochemistry, chemistry, chemical engineering or relevant scientific discipline.
o Quality professional with 10+ years of hands on experience with increasing responsibility in a quality function
o Prior responsibility over Quality Control and Quality Assurance activities.
o Significant hands on experience in a biopharmaceutical company, including clinical and commercial products.
o Hands on experience implementing quality systems in a GXP environment, and direct experience with FDA and other health authority inspections.
o Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU GMP requirements.
o Ability to critically evaluate and troubleshoot complex problems is essential.
o Strong hands on leadership and management skills.
o Ability to effectively participate on multi-disciplinary teams.
o Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
o Well-organized and detailed oriented professional, with strong verbal and written communication skills.
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North Carolina Biotechnology Center