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SUMMARY/JOB PURPOSE:
The Associate Compliance QA Director is responsible for QA oversight of the end-to-end vendor management program. This person will d evelop and maintain the approved vendor list and a apply quality risk management (QRM) and phase-based approach. This individual will oversee GxP vendor audits and monitor on-time report completi
Paradigm is a San Francisco-based crypto/web3 investment firm with approximately $8 billion in assets under management across multiple funds. We were co-founded in 2018 by Matt Huang (former Partner at Sequoia Capital) and Fred Ehrsam (co-founder of Coinbase). Paradigm makes investments in crypto-related companies and protocols agnostic to the stag
Mayfair is hiring a Director of Compliance to help us ensure security and confidentiality in our operations. You'll help guarantee compliance with all relevant legal requirements as we expand into new countries and partner with a variety of platforms to bring value to customers. The ideal candidate is precise, analytical, and detail-obsessed when i
Paradigm is a San Francisco-based crypto/web3 investment firm with approximately $8 billion in assets under management across multiple funds. We were co-founded in 2018 by Matt Huang (former Partner at Sequoia Capital) and Fred Ehrsam (co-founder of Coinbase). Paradigm makes investments in crypto-related companies and protocols agnostic to the stag
Senior Director Compliance
About the Company
Premium biopharma business
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Senior Director Compliance will be responsible for implementing a comprehensive training program, developing compliance policies, and providing strategic guidance and support.
Travel Percent
Less than 10%
Functio
As the Director of Quality Assurance (QA) & Release Management, you are someone who is obsessed with quality improvement with the ability to develop and drive a high-level strategy. You take a hands-on approach to implementing that strategy through Verification and Validation. Additionally, you thrive in a start-up environment and have experience i
As the Director of Quality Assurance (QA) & Release Management, you are someone who is obsessed with quality improvement with the ability to develop and drive a high-level strategy. You take a hands-on approach to implementing that strategy through Verification and Validation. Additionally, you thrive in a start-up environment and have experience i
As the Director of Quality Assurance (QA) & Release Management, you are someone who is obsessed with quality improvement with the ability to develop and drive a high-level strategy. You take a hands-on approach to implementing that strategy through Verification and Validation. Additionally, you thrive in a start-up environment and have experience i
Job Source: Zoox
Director of QA & Compliance
San Francisco, CA, United States
Director of QA & Compliance
About the Company
Expanding provider of clinical research site management services
Industry
Research
Type
Privately Held
About the Role
The Company is seeking a Director of Quality and Compliance to establish and maintain a robust quality program. The successful candidate will be responsible for evaluating, developing, and implementing standard operating procedures (SOPs) across all sites, as well as overseeing the quality management systems, training programs, and documentation processes. A key focus of the role is to ensure that the company's clinical research activities meet regulatory requirements and industry standards, with an emphasis on being "inspection ready at all times." The Director will also be involved in driving a culture of continuous quality and process improvement, leading and supporting staff during various audit activities, and serving as the primary point of contact for regulatory agencies and external auditors.Applicants for the Director of Quality and Compliance position at the company should have a Bachelor's degree in a related field, with a Master's degree preferred, and a minimum of 5 years' experience in quality and compliance roles within clinical research, particularly at the site level. The role requires in-depth knowledge of FDA regulations, ICH guidelines, and GCP standards, as well as experience in FDA inspections and sponsor audits. The ideal candidate will possess strong leadership and communication skills, the ability to influence and collaborate at all levels, and a passion for driving continuous improvement. Supervisory experience is a plus. The role demands a professional with the ability to balance quality with operational efficiency, create and deliver training at all levels, and work both independently and as part of a team. Meticulous attention to detail, the ability to maintain confidentiality, and a proactive approach to problem-solving are essential.