Job Description:
The Senior Manager, Quality Systems & Compliance is an advanced technical resource in the principles and application of quality systems and compliance. This role provides project management for strategic quality initiatives and ensures the tactical execution of QA engagement strategies.
The ideal candidate will have a background in Project Management as well as be proficient in data analysis while working with tools such as Excel, Power BI, Veeva, & Trackwise to be able to create dashboards. Experience implementing vendor KPI/scorecards is required as well.
Key Duties and Responsibilities
The responsibilities of this position may include, but are not limited to, the following:
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Function as a key partner to other operation functions (such as QA Operations and Manufacturing Technical Operations) in analyzing and interpreting technology needs and enable enterprise-wide digital mindset.
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Manage the creation and maintenance of compliance metrics for personnel training, document control, periodic review, events/CAPA, change controls and vendor performance scorecard.
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Identifies, analyzes, and interprets quality trends/patterns in complex data sets and prepares ongoing reports and data visualizations to support decision making.
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Generates and maintains metrics for Quality Management Reviews to permit effective governance of Vertex quality systems and activities.
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Lead in inspection readiness activities and lead quality development discussions.
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Driving functional excellence through tactical execution of quality compliance improvement activities.
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Provide project management leadership for QA department projects/initiatives as needed.
Basic Knowledge and Skills
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Experience using data analysis and visualization (e.g. Excel, Smartsheets, PowerBI, Tableau).
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Experience with GxP Systems (e.g. Veeva, Trackwise, Oracle, Labvantage).
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Highly skilled in Microsoft Excel, Word and Powerpoint.
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Specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing.
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Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action.
Preferred Knowledge and Skills
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Experience with Cell and Gene Therapy Products a plus.
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Exposure with multiple regulatory agencies across applicable GxPs during inspections.
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Experience leading complex 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.
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Able to be decisive, exercise good judgment in decisions, organized with the ability to prioritize a large workload
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Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience and advanced judgement and the analysis/synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions.
Education and Experience
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Bachelor’s degree in a scientific or allied health field (or equivalent degree)
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Typically requires at least 6 years of experience, or equivalent combination of education and experience
Pay Range:
$70-$80/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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No C2C or Third-Party Vendors