Commercial Quality Specialist

Purpose :

The Commercial Quality Specialist is responsible for independently providing Commercial Quality support within the affiliate covering quality system requirements related to pharmaceutical products medical devices combination products biologics. Key responsibilities include authorizing the release for sale of products that meet AbbVie quality and regulatory standards administering the product returns process and assisting with handling Product Quality Complaints when needed. The role also involves supporting the Quality Assurance Manager in managing affiliate documentation quality systems and the training matrix for the Quality Assurance Department to ensure compliance with all procedures legislative requirements and AbbVie global policies. Additional areas of support include overseeing Storage and Distribution addressing potential quality events or product shortages managing Supplier Controls and Product Quality Reviews participating in Risk Management Agency inspections / internal audits CAPA (Corrective and Preventive Actions) and fulfilling overall Quality Manual requirements. This ensures that all product process or system-related quality activities from receipt of final product through distribution align with Corporate governmental and local regulations.

Responsibilities :

• Responsible for the integration of local quality regulations for drugs biologics device and / or combination products.
• Design effective quality systems procedures and / or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
• Maintain and ensure the effectiveness of the Quality Management System in the affiliate supporting quality control assurance and regulatory compliance activities by Monitoring metrics and KPIs to ensure compliance.
• Authorize timely release of products to the market and manage retention samples in line with Quality Assurance procedures. Work on assessments to determine compliance to processes procedures and regulations to identify potential gaps and mitigate and implement improvements.
• Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
• Administer customer returns according to the Return Goods procedure.
• Support the effective management of Product Quality Complaints at the affiliate.
• Act as the Training Coordinator for the Quality Assurance department ensuring compliance with all required training activities.
• Initiate exception reports and manage CAPAs (Corrective and Preventive Actions) and effectivity checks as identified by the current Non-Conformance procedures.
• Initiate Change Plans and oversee related tasks to resolution.
• Assist in preparing quality reports for quarterly management reviews and participate in Product Quality Reviews.
• Support the supplier management program by maintaining updated lists of local TPMS and vendors qualifying suppliers / customers evaluating supplier performance monitoring supplier quality issues and coordinating timely failure investigations.
• Conduct assigned internal quality audits and external audits according to the audit schedule supporting the affiliates audit program.
• Assist with risk management activities including participation in risk meetings and verifying the implementation of risk mitigation in products and processes.
• Contribute to writing reviewing maintaining and approving Standard Operating Procedures for the Quality department.
• Support documentation maintenance and control as per applicable procedures.
• Act as Deputy Responsible Pharmacist during the absence of the Responsible Pharmacist. Represent Commercial Quality in cross functional teams projects and programs as assigned by management.

Qualifications :

Additional Information :

Key Stakeholders :   Local Affiliate Staff Commercial QA team Regulatory / Competent Authority Suppliers / Service Providers.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

No

Employment Type : Full-time

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Experience : years

Vacancy : 1