Senior Manager, Document Control & Training

How you’ll make an impact:

The Quality Assurance department is all about working collaboratively with our stakeholders to promote our Quality Culture and do things right. Whether it’s making sure documents are up to date, quality records are managed compliantly, or QMS data is compiled, we are driven by providing the highest quality products to our patients. Come work with a energized group of employees that loves rising to the challenge much as we do to support our patients and the 2seventy organization!

About the team:

The Senior Manager of Document Control and Training is responsible for ensuring that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets.

How you’ll spend your time:

• Manage the training and document management systems, processes, and initiatives while providing and executing innovative ideas to advance process efficiencies and system improvements.
• Ensure consistent, risk-based and innovative thought processes are employed to advise and make decisions.
• Manage the Document Control and Training Systems, logistics, delivery, metrics and maintenance while identifying and effectively resolving quality issues/discrepancies.
• Providing oversight of the team and managing their distribution of work.
• Managing the Cambridge site’s daily document management and training operations, including (but not limited to) ensuring appropriate documents standards are developed and managed, workflows are processed, and documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded.
• Globally owning and managing the document management and training business processes and the electronic systems supporting GxP documents and training needs, including (but not limited to) scaling business processes to match recent and future growth, developing and seeing through implementation of strategic plans and collaborating with global stakeholders to ensure that current and future processes and systems meet all user requirements.

Who you are and what you’ve accomplished:

• BA/BS, preferably in a scientific discipline with 7+ years of document control and training experience, 5+ of which are in a GxP-regulated industry; 5+ years of management experience
• Experience leading and owning a GxP training program, leading investigations into deviations with CAPA responsibility
• Extensive experience managing Document Control Systems
• Learning Management System (LMS) ownership, implementation, facilitation experience