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:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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.

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