Good Laboratory Practices, Quality Manager/Sr. Manager (Contract) 26240

The GLP Operational Quality Manager/Sr. Manager supports quality oversight for the GLP-related processes and activities. The incumbent will support business partners and GLP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas. The GLP Operational Quality Manager/Sr. Manager will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Manager/Sr. Manager, GLP Operational Quality will also collaborate with the Quality Analytics team to review and support the development of meaningful quality indicators to permit ongoing evaluation of process and quality system health and identification of risks.

Job Description

We are seeking a dedicated and experienced Good Laboratory Practice Quality Manager/Sr. Manager to support our company's quality oversight for GLP-related processes and activities. As a GLP Quality Manager, you will collaborate with various stakeholders and the GLP Operational Quality team to drive quality outcomes and operational excellence. Your primary responsibility will be to ensure compliance, excellence in quality, and readiness for future needs.

Key Responsibilities:

• Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence.
• Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality.
• Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, as well as risk identification.
• Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs.
• Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDA's.
• Provide input in the development of audit scope and focus for vendor audits.
• Contribute to pro-active inspection readiness activities by conducting quality assessments of GLP studies either on-site or remotely.
• Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities.
• Participate in creating and presenting content for annual GLP refresher training. Perform other duties as assigned.

Requirements:

• Bachelor's degree or equivalent in a related scientific field.
• Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions.
• Experience in Pharmaceuticals or Contract Research Organization (CRO)
• RQAP-GLP certification is preferred, but not mandatory.
• Ability to work independently and meet timelines in a fast-paced environment. Excellent communication and collaboration skills.

Travel Requirements:

This role may require up to 20% travel. Travel primarily includes visiting CROs for conducting Quality Reviews focused on data reviews. Some travel to Boston may be required for training or stakeholder engagement.

$75-$85/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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