Director, Quality Salary at Linkplas Ltd BETA

Title: Director, Quality Assurance (Drug Substance) Location: South San Francisco, CA Hybrid: 3-4 days a week onsite Compensation: Annual Salary of $230,000 Annual bonus of 20% plus equity in shares of options We are seeking an experienced professional to join our team as Director, of Quality Assurance. Qualified candidates must have worked directly with small molecules in the past, and have successfully taken late-stage NDAs from clinical trials to commercialization. This role will provide oversight of drug substance contract service providers (CSPs), develop and review quality agreements, lead batch disposition activities and support future commercialization. The candidate should have strong hands-on experience with developing, implementing, maintaining, and improving Quality System procedures using risk-based principles to ensure adherence to regulatory and Pliant requirements. Required skills Responsible for the disposition of drug substance, including review of master and executed

The Director of Quality Assurance will develop, implement, and evaluate quality assurance efforts, make recommendations, and ensure goals are met in the areas of overall service provision including: licensing, clinical and contract compliance, IDD se Quality Assurance, Director, Quality, Program Coordinator, Assurance, Support Professional, Technology

Director, Quality Assurance Overview of Role: The Director of Quality Assurance will lead the quality activities at Summit during clinical development and commercialization of drug candidates. Responsible for deviation resolutions, investigations, CAPAs, change controls batch record review, and development of robust quality systems. The Director of Quality Assurance will provide QA support in the preparation of quality sections of regulatory submissions. Role and Responsibilities: * Develop and implement GMP quality systems including all quality policies and procedures pertaining to GMP manufacture and testing in accordance with ICH, FDA, EMA and other global health authority regulations and industry standards * Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture. * Provide GXP compliance oversight for all vendors and CMOs and provide on-site oversight of CMO operations as needed * Lead and ensure GMP

Director, Quality Assurance Overview of Role: The Director of Quality Assurance will lead the quality activities at Summit during clinical development and commercialization of drug candidates. Responsible for deviation resolutions, investigations, CAPAs, change controls batch record review, and development of robust quality systems. The Director of Quality Assurance will provide QA support in the preparation of quality sections of regulatory submissions. Role and Responsibilities: * Develop and implement GMP quality systems including all quality policies and procedures pertaining to GMP manufacture and testing in accordance with ICH, FDA, EMA and other global health authority regulations and industry standards * Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture. * Provide GXP compliance oversight for all vendors and CMOs and provide on-site oversight of CMO operations as needed * Lead and ensure GMP

Description Position Description: This position in Quality Assurance provides strategic and technical support of the Quality Management System (QMS) and is responsible for ensuring GxP and QMS compliance. This position is responsible for ensuring Quality Programs are developed, implemented, and effectively administered in a manner that is fit for purpose, maximizes efficiency, complies with development-stage biotech industry standards, and achieves desired compliance with regulatory, clinical, and business operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP experience, and also have a strong desire and proven ability to implement quality initiatives across GxP functions. The candidate should have previous experience managing and mentoring others in Quality Assurance and be passionate about instilling a practical, efficient, and risk-based quality approach within the Quality Assurance group and throughout the company. Essential Duties

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Job Title** Director Quality Assurance **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO + An excellent retirement savings plan with hi

Director, Quality Assurance (Class II/Class III) What You'll Do: Responsible for managing company quality assurance systems including management review, document control, internal and external audits, complaint handling system, CAPA, training, and supplier quality system. Prepare reports to management on the performance of the quality system, including periodic management reports, management review meetings, and other reviews and recommendations for system improvements. Assist with the management and implementation of EDMS system. Who you are BS and e xperience working as a Quality Director or Associate Director at a Class II or higher medical device company. Combo product experience is a plus but not required. Must have experience establishing and sustaining Quality Systems and leading whole QA departments. Must have strong knowledge of US and International Quality System regulations and a desire to take ownership of QMS. Experience with EDMS implementation and deployment is highly pr

Director of Quality and Regulatory Aurora Medical Center Bay Area 3003 University Dr Marinette, WI 54143 Aurora Health Care – Midwest Region *Comprehensive Relocation Assistance available* Job ID # R128436 Schedule: Monday - Friday (with the ability to flex as needed to the hospital business needs) Hours: 8:00AM-4:30PM WHO WE ARE: Advocate Health is the nation’s third largest, nonprofit healthcare enterprise. In December of 2022, four mission driven health systems came together to do more, be better, and go faster to provide equitable care for all in North Carolina, South Carolina, Alabama, Georgia, Illinois, and Wisconsin: Atrium Health Advocate Health Care Aurora Health Care Wake Forest University School of Medicine Together, we operate 68 hospitals and over 1K ambulatory centers. We support the careers of 155K team members, 42K nurses, 21K physicians who care for 6M patients annually. Our combined $6B in community benefits enables us to foster healthier communities. Come explore the