Quality Assurance Manager, Distribution (Contract) 28814

Vertex Pharmaceuticals•Boston, MA

About The Position

The Manager role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the USA in compliance with GDP and GMP requirements. The Quality Manager will manage the day-to-day Quality oversight of the Third Party Logistics providers and provide support for key stakeholders within Vertex.

Requirements

Bachelor’s degree in a scientific or allied health field (or equivalent degree)
GDP work experience, or relevant comparable background.
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)
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 organizational and time management skills and able to demonstrate flexibility and adaptability.
Able to prioritize workload, decisive thinker, able to work within agreed timescales.
A high Level of attention to detail

Responsibilities

Support the oversight of Distribution Partners within the USA, including: Preparation and maintenance of Quality Agreements, Review of deviations, CAPA and changes, Maintaining KPIs
Analyze, resolve, or assist in solving compliance and customer issues.
Escalation of issues
Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
Working collaboratively with key internal stakeholders
Maintain QMS within the Vertex Pharmaceuticals Incorporated.
Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary
Support recalls, mock recalls and any other on-market activity.
Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements.
Planning/ Preparation/supporting/hosting for Regulatory inspections
Providing front and backroom inspection support
Post inspection follow-up with responses and CAPAs (Continuous improvements)