# Senior Staff, Manufacturing Technical Operations

**Company:** [BioPharma Consulting JAD Group](null/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Boston, United States
**Workplace:** on site
**Employment type:** Contract

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## Description

The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy T1D team.

**RESPONSIBILITIES**

-   Partner closely with functional area leads, maintain and actively monitor integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s)
-   Track and monitor key milestones and decision points and work with project team members to drive the completion of changes.
-   Effectively communicate with internal team members and key stakeholders on the status, objectives, risks, and mitigation plans associated with change control projects.
-   Organize and maintain team communications including meeting agendas, minutes, tasks lists, and risk analyses/mitigation strategies.
-   Update and maintain project status tools, such as a project action log and risk register.
-   Develop and deliver project management tools and templates to manage change control team activities.
-   Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

## Requirements

-   Bachelor’s degree in engineering, life sciences or related field.
-   A minimum of 8 years of experience in the biopharmaceutical industry.
-   A minimum of 6 years of experience in project management of biopharmaceutical product
-   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 & 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) 
-   Understanding of risk assessment.

**MUST HAVE:**

-   Proven history in managing and driving project success within the biotech industry.

-   Strong technical background, solid working knowledge of GMPs, 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.

## Benefits

-   1- year contract with possible extension
-   Administrative shift
-   Overtime availability