GxP Operations Support Manager

Job Description

General Summary:

The GxP Operations Support Manager will be responsible for supporting training documentation and electronic systems related to manufacturing and quality control at the Vertex Manufacturing Center (VMC). This role will primarily be responsible for creating, managing and delivering training content. The role may also involve serving as the business owner for QC laboratory computerized systems batch record and analytical data review, quality event ownership, and support for systems such as MES, LIMS, Tulip, and electronic training platforms.

Key Duties and Responsibilities:

• Manage the overall GxP training process, including hosting training sessions, assigning training modules, and maintaining up-to-date training materials to ensure compliance with regulatory and organizational standards
• Seeks and supports new approaches, practices and processes to improve the efficiency of training services offered
• Collaborate with stakeholders to develop and facilitate targeted training programs and workshops that address evolving organizational needs and enhance employee performance
• Create and maintain traditional and emerging training content
• Identify and continuously work to improve practices, procedures and activities as related to the department and site
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented
• Manage projects related to documentation, training, or electronic systems
• Own deviation, CAPA and Effectiveness Check (EC) and Change Control (CC) records in electronic Quality Management System (eQMS) and drive to completion by record due dates
• Interface with and manage QC laboratory computerized systems

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
• Experience with instructional design and facilitating training workshops for small and large groups
• Knowledge of adult education learning concepts and their application in the workplace

Education and Experience:

• Bachelor's degree with experience in a pharmaceutical or biotechnology manufacturing or quality control environment or the equivalent combination of education and experience in a related field
• 4 years of experience in a GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

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 ApplicationAssistance@vrtx.com