- Responsible for supporting Quality system oversight at CDMOs, metrics, and improvement including change control, events, CAPA, escalation, and risk management.
- Generates Metrics / KPIs, Dashboards and Reports.
- Leads and/or supports the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans.
- Provides hands-on expertise in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions.
- Assists Change Control, deviation, and CAPA owners with ensuring compliance to change procedure requirements.
- Supports internal audit or external audit programs.
- Provides Project Management coordination for department projects/initiatives.
- Identifies and implements continuous improvement to improve processes and make them efficient and scalable.
- Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
- Demonstrated leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Experience coordinating projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks.
- Ability to represent the Quality unit in cross-functional teams.
- Ability to communicate cross-functionally, exchange complex information, and influence others to understand a point of view and gain alignment around a proposed action.
- Demonstrated ability to work independently to provide QA advice for projects.
- Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
- Bachelor's degree in a scientific or allied health field (or equivalent degree).
- Typically requires 4 years of experience, or the equivalent combination of education and experience.
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Manager, Quality Systems and Compliance - Boston, United States - Vertex Pharmaceuticals
Description
Job Description:
The Quality Systems Manager is an advanced technical resource in the principles and application of quality systems and compliance. The role coordinates or executes alignment of procedures and processes related to the Quality Management System and helps drive Quality improvements. They coordinate projects and takes a role in the design and execution of processes.
This role is denoted as Hybrid = 3 days in office a week
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Minimum qualifications:
Knowledge and Skills:
Education and Experience:
$60-$70/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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