GxP Operations Support Manager

Vertex Inc. • Boston, MA

7d • Onsite

About The Position

The GxP Operations Support Manager will be responsible for supporting training documentation and electronic systems related to manufacturing and quality control at the Vertex Manufacturing Center (VMC). This role will primarily be responsible for creating, managing and delivering training content. The role may also involve serving as the business owner for QC laboratory computerized systems batch record and analytical data review, quality event ownership, and support for systems such as MES, LIMS, Tulip, and electronic training platforms.

Requirements

• Detail oriented with a focus on accuracy and timeliness
• Strong organizational skills and ability to balance changing priorities
• Effective communication skills, both verbal and written
• Proficiency with Microsoft Office suite
• Ability to learn new computer based systems
• Experience with instructional design and facilitating training workshops for small and large groups
• Knowledge of adult education learning concepts and their application in the workplace
• Bachelor’s degree with experience in a pharmaceutical or biotechnology manufacturing or quality control environment or the equivalent combination of education and experience in a related field
• 4 years of experience in a GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Responsibilities

• Manage the overall GxP training process, including hosting training sessions, assigning training modules, and maintaining up-to-date training materials to ensure compliance with regulatory and organizational standards
• Seeks and supports new approaches, practices and processes to improve the efficiency of training services offered
• Collaborate with stakeholders to develop and facilitate targeted training programs and workshops that address evolving organizational needs and enhance employee performance
• Create and maintain traditional and emerging training content
• Identify and continuously work to improve practices, procedures and activities as related to the department and site
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented
• Manage projects related to documentation, training, or electronic systems
• Own deviation, CAPA and Effectiveness Check (EC) and Change Control (CC) records in electronic Quality Management System (eQMS) and drive to completion by record due dates
• Interface with and manage QC laboratory computerized systems

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager