QA Manager (Responsible Person Lead) - Team of 3

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

QA Manager (Responsible Person Lead) - Team of 3

• Zwolle, OV
• Function: Operations
• Work location type: Hybrid
• Job Type: Full-time

Job Description

Reporting the Distribution Quality Manager, SCQA

The Quality Manager (RP lead) is responsible for management, leadership and oversight of the Responsible Persons of VLOG entities including Hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.

This role offers a strong opportunity to demonstrate both enterprise leadership and a continuous improvement mindset. The position extends beyond compliance and operational oversight, requiring the ability to influence across the supply chain, collaborate with diverse stakeholders, and make decisions that support broader organizational objectives. Success will come from continually identifying opportunities to improve processes, prevent quality risks, enhance efficiency, and develop team capabilities while fostering a culture of quality, accountability, and innovation

Highlighted Responsibilities:

• Provides leadership necessary to ensure that the quality of products and services by 3PL’s meet the highest AbbVie and Regulatory Agency standards.
• Acts as an internal local consultant on the principles of quality assurance and GDP.
• Assists Affiliate QA with quality related product actions (i.e., product QA hold actions, product recalls and market withdrawals) involving products distributed through VLOG.
• Drives process improvement opportunities that focus on reducing costs and prevention of distribution quality issues causing loss of product and/or loss of sales, and on ensuring product quality throughout the supply chain.
• Supervisory or managerial responsibility of QTA with CDC’s.
• Assures timely and diligent completion of training.
• Responsible for management, leadership and oversight of the SCQA officer of VLOG entity including Hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
• Assures documents related to distribution activities (including outsourced ones) are up to date and managed in the approved AbbVie system.

Qualifications

• University degree is desirable (Bio-Medical Science, Pharmacy).
• 3+ years work experience in a GDP environment is preferred including supervisory or management experience.
• A registration as Responsible Person with the Dutch MOH is required.
• Knowledge of applicable regulations, quality systems, and principles of quality assurance.
• Experience with Quality systems and Quality Assurance in an operational setting with demonstrated knowledge of techniques for assessing the quality of processes.
• Knowledge of regulations, guidelines and standards related to manufacturing and distribution of medicinal products and medical devices.
• Technical experience in the following areas is desired: logistics, materials management, production, engineering, computer science, quality control/assurance, and compliance/regulatory.
• Proven process improvement and/or product development experience in an industrial setting with demonstration of effective communication, teamwork, problem solving and conflict resolution skills.
• Must possess excellent helicopter view and analytical skills.
• Excellent written and oral Dutch and English communication skills are required.

Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location.