Associate Director, GxP Operations Support Lab Systems

Posted 8 Days Ago
Be an Early Applicant
Boston, MA, USA
In-Office
162K-242K Annually
Senior level
Biotech • Pharmaceutical
The Role
Lead GxP documentation and electronic lab systems support at the manufacturing center, overseeing SOPs/WIs/batch records, eQMS deviation/CAPA/change control, LIMS/MES/Tulip/electronic training, data reviews, KPI monitoring, process improvements, and management of a team.
Summary Generated by Built In

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 [email protected]

Skills Required

  • 8 years of experience in a GMP pharmaceutical/biopharmaceutical industry or equivalent
  • Bachelor's degree or high school diploma with relevant pharmaceutical/biotech manufacturing or quality control experience
  • Experience in direct oversight or management of personnel
  • Experience with electronic Quality Management Systems (eQMS) and management of deviation, CAPA, effectiveness checks, and change control records
  • Experience implementing/optimizing and managing electronic systems such as LIMS, MES, Tulip, and electronic work instructions/training
  • Proficiency with Microsoft Office suite
  • Strong verbal and written communication, attention to detail, and organizational skills
  • Ability to develop and monitor KPIs and drive process and documentation improvements

Vertex Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.

  • Parental & Family Support Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
  • Leave & Time Off Breadth Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
  • Retirement Support Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.

Vertex Pharmaceuticals Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Boston, MA
5,000 Employees
Year Founded: 1989

What We Do

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.

Similar Jobs

SharkNinja Logo SharkNinja

Influencer Manager, Social

Beauty • Robotics • Design • Appliances • Manufacturing
In-Office
Needham, MA, USA
4000 Employees
79K-155K Annually

SharkNinja Logo SharkNinja

Social Acceleration Manager, Americas

Beauty • Robotics • Design • Appliances • Manufacturing
In-Office
Needham, MA, USA
4000 Employees
122K-148K Annually

SharkNinja Logo SharkNinja

Marketing Manager

Beauty • Robotics • Design • Appliances • Manufacturing
In-Office
Needham, MA, USA
4000 Employees
82K-165K Annually

SharkNinja Logo SharkNinja

Program Manager

Beauty • Robotics • Design • Appliances • Manufacturing
In-Office
Needham, MA, USA
4000 Employees
62K-95K Annually

Similar Companies Hiring

SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account