Director, QMS
1 month ago
Job Title: Director of Quality Management Systems (QMS)
About:
Our client
is a dynamic and innovative biotechnology company located in the San Francisco Bay Area. They are dedicated to advancing healthcare through groundbreaking research, development, and commercialization of novel therapeutics. With a commitment to quality, integrity, and patient-centricity, they strive to make a meaningful impact on global health.
Position Overview:
We are seeking an experienced and strategic-minded Director of Quality Management Systems (QMS) to join their growing team. The Director of QMS will be responsible for developing, implementing, and maintaining a robust Quality Management System to ensure compliance with regulatory requirements, drive continuous improvement, and uphold the highest standards of quality across all aspects of our operations.
Key Responsibilities:
Lead the development, implementation, and maintenance of the company's Quality Management System (QMS) in accordance with applicable regulatory requirements, including but not limited to FDA, ISO, and other relevant standards.
Establish and oversee quality policies, procedures, and processes to ensure compliance, consistency, and efficiency throughout the organization.
Provide leadership and guidance to cross-functional teams on quality-related matters, fostering a culture of quality and continuous improvement.
Collaborate with internal stakeholders, including Quality Assurance, Regulatory Affairs, Research & Development, Manufacturing, and Clinical Operations, to ensure alignment and integration of quality objectives across the organization.
Lead and support internal and external audits, inspections, and regulatory submissions, ensuring readiness and compliance with regulatory requirements.
Drive corrective and preventive actions (CAPAs) and root cause analyses (RCAs) to address quality issues and drive sustainable improvements.
Stay current with industry trends, regulations, and best practices related to quality management systems and quality assurance.
Manage and develop a team of quality professionals, providing mentorship, training, and guidance to support their growth and development.
Qualifications:
Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
Minimum of 6 years of experience in quality assurance, quality management systems, or related field within the biotechnology or pharmaceutical industry.
In-depth knowledge of regulatory requirements, standards, and guidelines applicable to biopharmaceutical quality systems (e.g., FDA regulations, ISO standards).
Proven track record of successfully developing, implementing, and maintaining Quality Management Systems in a regulated environment.
Strong leadership skills with the ability to influence and collaborate effectively across functions and levels of the organization.
Excellent communication, presentation, and interpersonal skills.
Detail-oriented with strong analytical and problem-solving abilities.
Experience leading and managing a team of quality professionals.
Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or similar certifications preferred.
#J-18808-Ljbffr
-
Director GCP Quality
5 hours ago
Los Angeles, United States SciPro Inc. Full timeSenior Director GCP Quality – San Francisco A mid-size, Clinical stage Biopharmaceutical in the Cell & Gene Therapy space based in the Bay Area of San Francisco is currently looking for a seasoned professional to fill a brand new position as Director of GCP Compliance. This is a role where you'll be responsible for creating programs around Quality, Risk...
-
Manager Quality and Risk Management
1 month ago
Los Angeles, United States Arroyo Vista Family Health Center Full timeJob DescriptionJob DescriptionSalary Range: $87,500 to $95,000 AnnuallySummary:Under the direct supervision of the Quality Management/Risk Management Director, the Quality Management/Risk Management Manager is responsible for providing management support to the Agency’s Quality Management/ Risk Management Program, to include The Joint Commission Ambulatory...
-
Los Angeles, United States Preferred IPA of California Full timeJob Description Job Description Openings for both a Quality Compliance Nurse and a Compliance Coordinator. QUALITY COMPLIANCE NURSE PURPOSE: The Quality and Compliance Nurse is responsible for working with the Medical Director, the VP of Clinical Policy, the QM Committee in developing, implementing, and refining the Quality Management Program. They are also...
-
Associate Medical Director
4 weeks ago
Los Angeles, United States MedPOINT Management Full timeJob DescriptionJob Description MedPOINT Management (MPM)Department: Utilization Management (UM)Title Associate Medical Director SummaryThe Associate Medical Director is responsible for providing medical interpretation and decisions about appropriateness of services provided by other healthcare professionals in compliance with Utilization Management...
-
Associate Medical Director
1 month ago
Los Angeles, United States MedPOINT Management Full timeJob DescriptionJob Description MedPOINT Management (MPM)Department: Utilization Management (UM)Title Associate Medical Director SummaryThe Associate Medical Director is responsible for providing medical interpretation and decisions about appropriateness of services provided by other healthcare professionals in compliance with Utilization Management...
-
Los Angeles, United States Preferred IPA of California Full timeJob DescriptionJob DescriptionOpenings for both a Quality Compliance Nurse and a Compliance Coordinator. QUALITY COMPLIANCE NURSEPURPOSE:The Quality and Compliance Nurse is responsible for working with the Medical Director, the VP of Clinical Policy, the QM Committee in developing, implementing, and refining the Quality Management Program. They are also...
-
Medical Doctor
3 weeks ago
Los Angeles, United States APLA Health Full timePOSITION SUMMARY:Under the direction of the APLA Health Site Medical Director, provides primary medical care for adults at the Long Beach Health Center and other APLA Health clinical sites. The Long Beach Health Center physician participates in forming the health centers’ medical protocols and programs, in accordance with APLA policies. APLA Health’s...
-
Medical Doctor
3 weeks ago
Los Angeles, United States APLA Health Full timePOSITION SUMMARY:Under the direction of the APLA Health Site Medical Director, provides primary medical care for adults at the Long Beach Health Center and other APLA Health clinical sites. The Long Beach Health Center physician participates in forming the health centers’ medical protocols and programs, in accordance with APLA policies. APLA Health’s...
-
Medical Doctor
3 weeks ago
Los Angeles, United States APLA Health Full timePOSITION SUMMARY:Under the direction of the APLA Health Site Medical Director, provides primary medical care for adults at the Long Beach Health Center and other APLA Health clinical sites. The Long Beach Health Center physician participates in forming the health centers’ medical protocols and programs, in accordance with APLA policies. APLA Health’s...
-
Medical Doctor
3 weeks ago
Los Angeles, CA, United States APLA Health Full timePOSITION SUMMARY:Under the direction of the APLA Health Site Medical Director, provides primary medical care for adults at the Long Beach Health Center and other APLA Health clinical sites. The Long Beach Health Center physician participates in forming the health centers’ medical protocols and programs, in accordance with APLA policies. APLA Health’s...
