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Temp Change Control Jobs in Massachusetts (NOW HIRING)

Northeastern University

Project Manager

Boston, MA · On-site

$40 - $70/hr

Manage changes to project scope, schedule, and budget using formal change control processes ... Position Type Temporary Additional Information Northeastern University considers factors such as ...

NorthEastern

Project Manager

Boston, MA · On-site +1

$40 - $70/hr

Manage changes to project scope, schedule, and budget using formal change control processes ... Position Type Temporary Additional Information Northeastern University considers factors such as ...

Actalent

Quality Control Analyst

Cambridge, MA

$35 - $40/hr

Benefits are subject to change and may be subject to specific elections, plan, or program terms. If ... this temporary role may include the following: * Medical, dental & vision * Critical Illness ...

Pfizer

USA - Process Engineer - III - USD

Andover, MA · On-site

$95.05 - $99.19/hr

Partner with Quality and Validation teams to support system qualification, change control, and ... This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The ...

Senior plc

Senior Supplier Quality Engineer

Sharon, MA · On-site

$93K - $120K/yr

Lead validation, qualification, and change control activities through thorough documentation and ... Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to ...

Berklee College of Music

Registrar

Boston, MA · On-site

$145K - $170K/yr

This position is a 1-year temporary role with full benefits. The Office of Enrollment Strategy ... Change Control: Serve on the Workday Operations Committee to approve cross-functional system ...

Senior plc

Senior Supplier Quality Engineer

Sharon, MA · On-site

$93K - $120K/yr

Lead validation, qualification, and change control activities through thorough documentation and ... Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to ...

Boston Conservatory

Registrar

Boston, MA

$145K - $170K/yr

This position is a 1-year temporary role with full benefits. The Office of Enrollment Strategy ... Change Control: Serve on the Workday Operations Committee to approve cross-functional system ...

Senior plc

Senior Supplier Quality Engineer

Sharon, MA · On-site

$93K - $120K/yr

Lead validation, qualification, and change control activities through thorough documentation and ... Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to ...

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Quality Change Control, Project Manager (Contract) 665

Vertex Pharmaceuticals

Boston, MA • On-site

$80 - $90/hr

Other

Posted 5 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical

Job description

Job 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.

Must be detail-driven and have a proven history in managing and driving project success within the biotech industry. The individual requires a 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. Must have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.

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.
  • Write Risk Assessments
  • 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

QUALIFICATIONS

  • 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)
Pay Range

$58-$65/hr

Requisition Disclaimer

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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