Associate Director, GxP Operations Support Lab Systems

Job Description

General Summary:

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.

Key Duties and 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

Knowledge and Skills:

• 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

Education and Experience:

• 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

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]