CAPA Manager (contract)

Title/Role: CAPA Manager

Area:Manufacturing Technical Operations (MTO)

GENERAL POSITION SUMMARY:

The CAPA Manager is responsible for supporting the MTO and cross-functional teams initiating implementing and closing CAPAs developing and distributing CAPA and training compliance metrics reporting on CAPA and training trends and overseeing training structure and assignment. Candidates should be comfortable adapting to evolving priorities and staying flexible.

Must be detail-driven and have a proven history in meeting deadlines and driving success within the biotech industry. The individual requires a strong technical background solid working knowledge of GMPs experience working with LMS understanding of the drug development pathway through commercialization and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset. Must have excellent communication skills written and verbal high attention to detail and the ability to work effectively in cross-functional matrixed teams.

RESPONSIBILITIES:

• Oversee training structure curricula and assignment for MTO and cross-functional teams.

• Effectively communicate with internal team members and key stakeholders on the objectives mitigation plans and development of meaningful CAPAs.
• Track and monitor key milestones and work with cross functional team members to drive the completion of CAPAs.
• Organize and maintain team communications including meeting agendas minutes and follow up task lists.
• Develop and deliver project management tools and templates to manage CAPA and Training team activities.
• Consistently perform duties within established SOPs and in accordance with GxP requirements where applicable

QUALIFICATIONS:

• Bachelors degree in engineering life sciences or related field.
• A minimum of 8 years of experience in the biopharmaceutical industry.
• Working knowledge of biotechnology GMPs and drug development lifecycle.
• Ability to work effectively in cross-functional matrixed environment prioritizing and managing multiple tasks simultaneously integrating cross-functional issues and balancing competing priorities effectively.
• Expertise in Microsoft suite (Project PowerPoint SharePoint Word Excel Outlook). Experience with other PM tools a plus (e.g. Smartsheet Power BI etc.).
• Excellent oral and written communication skills including presentation and facilitation skills to effectively inform key updates and issues across all levels of the organization.
• Strong analytical problem solving and critical thinking skills including an ability to combine attention to detail with a big picture perspective.

• Strong understanding of regulatory requirements (FDA 21 CFR Part 211 EU GMP ICH Q10)

$60-$65/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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