Job Description

General Summary:

The GDP Operational Quality Specialist will work cross-functionally to support the training needs of business partners within the French affiliate and will support QMS maintenance (deviation, CAPA, change control management, …).

Key Duties and Responsibilities:

• Responsible for managing the intake, triage and entering Vertex France internal deviations into the quality system. Liaise with relevant stakeholders to obtain full information to initiate investigation and root cause analysis as per Vertex procedures. Track completion and closure in a timely manner and trend events related to processes.

• Track Vertex France deviations, change controls, CAPAs, Effectiveness checks, SMF, SOPs and TQAs for timely updates.

• Support International QA in coordinating product returns for Vertex France, where required.

• Support RP in gathering relevant documentation for disposition on temperature excursions.

• Complete any quality actions assigned (updating quality documents, issuing memos etc)

• Raise risks/issues with timelines and seek support in timely resolution.

• Initiate change control records as required.

• Support inspection readiness activities as well as tracking post-inspection CAPA action completion timelines.

• Provide audit and inspection support for processes.

• Define and optimise work processes and serve as Document Owner and SME

• Utilize and boost learnings from audits/inspections to advance inspection readiness.

• File quality records according to Vertex records retention policy and procedures.

• Collaborate with internal and external stakeholders supporting Vertex France and International QA team to manage other the day-to-day QA Operations.

• Collaborate with Process Owners, Curricula Owners, and Functional Area Management (FAM) to determine Process Change Request (PCR) training assignments for Vertex France Exploitant employees (initial and continuous).

• Together with RP review and assess role-based curricula structure in the GxP Training Catalog to confirm accuracy and relevance to role.

• Support affiliate functional People Managers and employees with GxP and product related training assignments within LMS.

• Act as functional area point of contact for employee training related tasks and reports

• Participate in Training Coordinator Community of Practice (CoP) to learn and share best practices.

Knowledge and Skills:

• Ability to work under moderate supervision
• Ability to work and coordinate cross-functionally
• Experience with and ability to use Microsoft Office and associated tools (Word, Excel, PowerPoint)
• Fluent in verbal and written English
• Experience with e-learning software (Articulate Storyline, Adobe Captivate)
• Ability to help develop and deliver effective training; understands and applies basic concepts around varying learning styles
• Demonstrated experience with handling compliance issues, resulting from deviations or product defects
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and inter-departmental teams
• Excellent communication and interactive skills
• Technical Writing
• Good organisational and time management skills and able to demonstrate flexibility and adaptability.
• Able to prioritise workload, decisive thinker able to work within agreed timescales.
• A high Level of attention to detail.

Education and Experience:

• Life-sciences degree (preferred pharmacist degree)
• Bachelor/Master Degree in quality assurance
• Typically requires 2 years of relevant work experience or the equivalent combination of education and experience

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: 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.

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