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myGwork - LGBTQ+ Business Community · 2 days ago
Senior Project Quality & Risk Lead
United States
Full-time
Hybrid
Senior Level
6+ years exp
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Responsibilities
Analyze key risk indicators and investigate risk signals for assigned projects.
Facilitate and support the risk management process for projects.
Identify, investigate, and remediate quality issues for assigned studies.
Assist in audit/inspection preparations, conduct, and response/action plan development.
Provide expert quality advice, respond to consultancy requests, and deviations.
Partner with project teams to achieve and maintain an inspection-ready state.
Develop transparent quality relationships with clients and identify areas for continuous improvement.
Maintain compliance with standards, mentor PQRLs and EP Quality Specialist.
Demonstrate excellent interpersonal, verbal, and written communication skills.
Utilize superior analytical skills to identify issues and assess effectiveness of actions.
Adapt to changing environments, manage workload independently, and value teamwork.
Manage complexity in a matrix environment and focus on patient and client needs.
Qualification
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Required
6+ years' experience in clinical research
Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development
Expertise with ICH-GCP principles
English proficiency (written and oral)
Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.
Preferred
Master's Degree in a science, technology or industry-related discipline
Ability to travel 10% - 15%
Benefits
Health Insurance
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Leadership Team
Adrien Gaubert
Co-Founder & CMO
Recent News
2024-04-10
Company data provided by crunchbase
