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Steneral
Baltimore, MD, United States
Location: Baltimore, MD - Must be on site 2 days a week. Ideal candidate is local to that region but they can be 2-3 hours a way as long as they are open to being in the office two days a week Interview Process: 3 rounds, maybe a 4th. Remote and then in person for final round Our client, a Global Leading Investment firm in business since 1937, is
Job Source: SteneralThe University of Melbourne
Parkville, MD, United States
Head, School of Population and Global Health Salary : Level E Professor, an attractive salary package will be negotiated with the successful candidate. Superannuation: Employer Contribution of 17% Working Hours: Full Time 1.0FTE Basis of Employment: 5 years, with opportunity for extension Opportunity Step into a pivotal leadership role at the
Job Source: The University of MelbourneCanonical - Jobs
Baltimore, MD, United States
Job Description Job Description We have created a role for a dedicated Global Head of Finance Services Industry (FSI) to lead go-to market strategy and be accountable for the global growth of Canonical in that sector. The successful candidate will drive our sales in the FSI vertical and inform our marketing, alliances, and product investments to
Job Source: Canonical - JobsMorgan Stanley
Baltimore, MD, United States
About Morgan Stanley Discover your next career opportunity with Morgan Stanley, where we are committed to helping our employees build meaningful careers, and where you can learn, achieve, and grow. Across the globe, we believe our greatest asset is our people. As part of our commitment to excellence, and to you, we offer a comprehensive suite of be
Job Source: Morgan StanleyMorgan Stanley
Baltimore
*About Morgan Stanley* Discover your next career opportunity with Morgan Stanley, where we are committed to helping our employees build meaningful careers, and where you can learn, achieve, and grow. Across the globe, we believe our greatest asset is our people. As part of our commitment to excellence, and to you, we offer a comprehensive suite of
Job Source: Morgan StanleyFLASH Technology Group
Columbia, MD, United States
The Quality/Ticket Coordinator I, as part of a 24x7 Service Desk, perform the activities associated with the management of dedicated ticket queues to include prioritization of work and assignment to technical resources for resolution of end user concerns while ensuring service levels and objectives are met. Responsibilities include: -Monitoring
Job Source: FLASH Technology GroupCSL Behring LTD
Baltimore, MD, United States
The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or compa
Job Source: CSL Behring LTDCatalent Inc
Baltimore, MD, United States
**Quality Auditor** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is comm
Job Source: Catalent Inc, MD, United States
Global Head of Quality
As the Global Head of Quality, you will be responsible for ensuring the highest standards of quality across multiple international sites, encompassing approximately 200 employees. You will play a pivotal role in overseeing Quality Management System (QMS) integration, CDMO (Contract Development and Manufacturing Organization) operations, Biologics and CAR-T product manufacturing, and compliance with cGMP standards. This role requires a strong understanding of FDA and EMA regulatory requirements, as well as experience managing and navigating audits from these regulatory bodies.
Key Responsibilities:
Lead and manage a global team of Quality Assurance professionals to ensure consistent adherence to cGMP standards and regulatory requirements.
Develop and implement global quality strategies and initiatives that align with corporate objectives and regulatory expectations.
Oversee the integration and harmonization of Quality Management Systems across all sites, promoting efficiency and standardization.
Provide oversight and support for all aspects of CDMO operations related to Biologics and CAR-T product manufacturing.
Collaborate closely with cross-functional teams including Manufacturing, Regulatory Affairs, and R&D to drive continuous improvement in quality processes and systems.
Serve as the primary point of contact for FDA and EMA inspections and audits, ensuring readiness and compliance at all times.
Monitor and analyze quality metrics and KPIs to identify trends, implement corrective actions, and drive a culture of quality excellence.
Champion a culture of quality and compliance throughout the organization, promoting awareness and accountability at all levels.
Qualifications:
Bachelor's degree in a scientific or engineering discipline; advanced degree (Master's, PhD) preferred.
Minimum of 15 years of progressive experience in Quality Assurance within the biopharmaceutical industry, with at least 5 years in a leadership role overseeing global operations.
Extensive knowledge and experience with Biologics and/or CAR-T product manufacturing processes and regulatory requirements.
Proven track record of successfully managing FDA and EMA audits and inspections.
Strong leadership and communication skills with the ability to influence and collaborate across diverse teams and cultures.
Strategic thinker with the ability to translate strategic plans into actionable quality initiatives.
Experience in implementing and maintaining effective QMS across multiple international sites is highly desirable.
Ability to travel internationally as needed (approximately 30-40% travel expected).
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Email Alert for Global Head of Quality jobs in , MD, United States
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