• , US

Company:  Confidential

Job Title: Director, GMP Quality Assurance

Job Number: 72266

Location: , US

Job Description

* Head GMP QA and ensure a culture of continuous improvement * Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards * Provide QA oversight of device development activities (pre-filled syringes, autoinjectors, etc.)  * Develop and maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and batch record review and disposition, to guarantee the consistent production of high-quality products * Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures * Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization * Establish and report key quality metrics to monitor performance and drive improvements in GMP compliance and product quality * Lead the GMP vendor qualification program and activities including audits, assessments, and quality agreement negotiation to ensure quality of clinical trial materials and services * Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness * Ensure personnel are adequately trained in GMP requirements and quality procedures * Maintain comprehensive and accurate records and reports related to quality assurance activities * Lead GMP inspection readiness activities to support regulatory authority inspections


* A Bachelor’s or Master’s degree in a relevant scientific discipline or equivalent * A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with progressive leadership experience * Experience and knowledge of medical device Quality System Regulations preferred * Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators * In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements * Strong leadership, communication, and interpersonal skills with the ability to influence and drive change * Excellent problem-solving and critical thinking abilities * Ability to manage multiple projects with aggressive timelines and changing priorities * Ability and willingness to travel up to 20% (approximately 8-12 times per year for company meetings)

Application Deadline: 2024-03-18


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