Lead Manager, Quality Assurance and Training

2 weeks ago


Boston Massachusetts, United States Vertex Pharmaceuticals Full time

Position Overview:


The Lead Manager of Quality Assurance and Training will play a pivotal role within the GxP Process Operation Center (GPOC), taking charge of driving and/or supporting strategic initiatives while establishing the Quality Project Lifecycle and Change Management framework within our Quality division.

This position will report to the (associate) Director of Quality Assurance, Training, and Enhancements.


In this capacity, you will influence and transform our GxP documentation and training process capabilities, focusing on their effectiveness, efficiency, reliability, ownership, and scalability.

This involves collaborating with Quality process and system owners to perpetually enhance processes.


As our Quality Organization continues to support ongoing operations, we are also committed to enhancing and evolving our processes to align with the future vision of our organization.

This individual will be instrumental in driving this evolution.

The ability to devise and implement change strategies, lead cross-functional teams, and facilitate decision-making, as well as effectively collaborate with cross-functional business stakeholders for impactful results, will be crucial for success in this role.

You will be accountable for promoting process excellence, continuous enhancement, and project management in an area where technology and business frequently intersect.

Your proficiency in change management and agile methodologies will be invaluable in ensuring the success of our quality initiatives.

The ideal candidate will possess experience in managing projects, portfolio management, and execution.

Key Responsibilities:
Provide guidance to consistently enhance processes governing GxP controlled documents (e.g., Standard Operating Procedures, Work Instructions) and GxP training programs/courses.


Collaborate with Quality and business stakeholders/leaders across GxP domains to advance process ownership, governance, systems, and processes that are fit-for-purpose, effective, and sustainable.

Establish a continuous improvement roadmap, define and monitor improvement targets, and drive cross-functional transformations in alignment with the strategic Quality roadmap.

Foster a culture of process excellence across Quality functions.

Essential Knowledge, Skills, and Competencies:

Proven strategic planning and operational execution capabilities.

Innovative leadership experience complemented by change management expertise, adaptability, and resourcefulness.

Exceptional communication and facilitation skills with a demonstrated history of promoting a continuous improvement mindset.

Strong problem-solving and critical thinking abilities, along with analytical thinking/data analysis skills.

Experience in Operational Excellence with a proven ability to lead improvement projects that often involve technology components.

Familiarity with controlled/regulatory environments and technological enhancements in these systems.

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