Associate Director, GxP Operations Support Lab Systems

Job Description

General Summary:

The Associate Director, GxP Operations Support Lab Systems will play a critical role in supporting the laboratory information management systems (LIMS) through ongoing maintenance of implemented features and implementation of new functionality. This position will serve as the Business Owner for the LabVantage LIMS across all Vertex modalities. The role also involves supervising a team both directly and indirectly.

Key Duties and Responsibilities:

• Lead the implementation, optimization, and master data management of LIMS
• Support digital strategies enabling real-time execution, electronic workflow orchestration, automated data collection, equipment/system integration, analytics and reporting
• Oversee technical review of analytical and manufacturing data and documentation
• Manage and own deviation, CAPA, Effectiveness Check (EC), and Change Control (CC) records in the electronic Quality Management System (eQMS)
• Facilitate and lead improvements to LIMS documentation, procedures, processes, and training to enhance efficiency and ensure best practices
• Conduct and supervise LIMS training ensuring consistent and effective execution
• Develop and monitor Key Process Indicators (KPIs) related to the LIMS system
• Mentor, motivate, and evaluate the performance of team members, establishing performance objectives aligned with company goals

Knowledge and Skills:

• Proficiency with Microsoft Office Suite
• Strong organizational skills with the ability to balance changing priorities
• Effective verbal and written communication skills
• Detail-oriented with a focus on accuracy and timeliness
• Ability to learn and adapt to new computer-based systems

Education and Experience:

• Bachelor’s degree or equivalent combination of education and experience in a pharmaceutical or biotechnology manufacturing or quality control environment
• Minimum of 8 years of experience in a GMP pharmaceutical/biopharmaceutical industry
• Proven experience in implementing and managing LIMS, particularly LabVantage
• Direct oversight or management of personnel

Pay Range:

$161,500 - $242,300

Disclosure Statement:

Flex Designation:

On-Site Designated

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 ApplicationAssistance@vrtx.com