Associate Director, GxP Operations Support Lab Systems

Vertex Inc.•Boston, MA

1d•$161,500 - $242,300•Onsite

About The Position

The Associate Director, GxP Operations Support Lab Systems will be responsible for supporting documentation and electronic systems related to manufacturing and quality control at the Vertex Manufacturing Center (VMC). This includes overseeing the writing and editing of SOPs, WIs, batch records, training content, and other related documentation, batch record and analytical data review, quality event ownership, and support of MES, LIMS, Tulip, and electronic training. This position also includes group supervision and management.

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
Ability to manage and develop a diverse group of individual contributors
Bachelor’s degree or high school diploma with experience in a pharmaceutical or biotechnology manufacturing or quality control environment or the equivalent combination of education and experience in a related field.
8 years of experience in a GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
Experience in direct oversight or management of personnel

Responsibilities

Management and ownership of deviation, CAPA and Effectiveness Check (EC) and Change Control (CC) records in electronic Quality Management System (eQMS)
Identify and continuously work to improve practices, procedures and activities as related to the department and site
Facilitate and lead improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented
Oversight of technical review of analytical and manufacturing data and documentation
Oversight of GxP training including assignment of training and creation and revisions of training material
Implementation, optimization, and master data management of electronic systems such as LIMS, MES, Tulip, and electronic WIs
May be a SME, trainer, process owner, or business owner
Development and monitoring of Key Process Indicators (KPI) related to documentation, training or electronic systems
Mentor, motivate, and evaluate the performance of group members
Establish and monitor performance objectives for staff that are consistent with department, site and company goals