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Quality Director, Good Tissue Practices (Contract) 2052

Ver-Tex
Boston, MA Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/4/2025

Job Description The Director of Quality will focus on Good Tissue Practices and assessment and implementation of regulations. The position must work cross-functionally across the organization and have excellent communication and collaboration skills. The candidate must have experience working with EU regulations for tissue licensing as well as Import / Export Tissue experience.Key Duties & ResponsibilitiesLead the cross-functional team to assess the impact of regulations to the Vertex organization.Provide guidance and expertise to the team on regulatory expectations, standard practices in the industry, and options for implementation.Work cross-functionally and collaboratively to evaluate the quality systems and processes across the Vertex organization and across GxPs to ensure full impact is evaluated, assessed, and documented.Organize, lead, and develop strategy for implementation as well as projected timelines and potential critical path items.Report out on the progress of the program, status, and identified issues.Identify and escalate risks as required.Required Education LevelBachelor's degree in a scientific discipline, operations research, operations management, or a related fieldRequired ExperienceTypically requires 5-10 years of relevant experience or the equivalent combination of education and experienceRequired Knowledge / SkillsExpert knowledge of global GTP requirements governing CGT productsAbility to evaluate quality matters and make decisions utilizing risk-based approachSolid quality culture knowledge and understanding of how to influence without authoritySuperb facilitation, communication, and coaching / influencing skills with proven ability to lead teamsExperience across multiple GxP areasProven ability to identify and analyze performance indicators.Pay Range $100-$115 / hr#J-18808-Ljbffr

Salary : $100 - $115

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