Senior QA Specialist

Company Description

The firm’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Aesthetics portfolio

Job Description
The Commercial Quality Specialist is responsible for independently providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. The Sr. Specialist has an in- depth knowledge of one or more elements and is considered a subject matter expert in these areas. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.

• Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
• Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
• Plan, prepare, review and approve quality documentation such as change controls, product reviews and other local requirements.
• Support internal, external and MoH audits as directed by the manager, lead self inspections.
• Coordinate and investigate quality events such as deviations, non conformances and corresponding action plans including decisions.
• Execute supplier qualification program including performance monitoring for key suppliers.
• Monitor metrics and KPIs to ensure compliance.
• Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Support the Management Review process for the affiliate.
• Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 3+ years’ experience in quality assurance, GMP or GDP environment preferred.
• Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
• Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics with an in-depth knowledge in one or more areas
• General knowledge and understanding of pharmaceutical, biologic and cosmetic products and regulations.
• Ability to support projects as a team member or lead as assigned by manager
• Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Make decisions in collaboration with management
• Acts as an owner - uses available resources to independently complete assigned tasks
• Influencing - Understand your stakeholders and shape communication; can negotiate to win
• Personal Presence - Demonstrate the confidence that matches their subject matter expertise and intellectual capacity