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:
$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