Quality Director, Good Tissue Practices (Contract) 2052 - Vertex Pharmaceuticals

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 & Responsibilities

• Lead 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 Level

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field

Required Experience

• Typically requires 5-10 years of relevant experience or the equivalent combination of education and experience

Required Knowledge/Skills

• Expert knowledge of global GTP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Solid quality culture knowledge and understanding of how to influence without authority
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

$100-$115/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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