Global QA/RA Director

Short Description

Our client is a global leader in clinical and commercial packaging solutions for the pharmaceutical and biotech industry. With state-of-the-art facilities and a strong reputation for quality, innovation, and compliance, the company supports customers throughout the full product lifecycle—from design to delivery.

To strengthen its global Quality organization, we are recruiting a: Global QA/RA Director

Requirements

As Global QA/RA Director, you will:

• Report directly to the SVP Global Quality (dotted line to the SVP & Managing Director Clinical & Europe).

• Be an active member of both the European Commercial Management Team and the Global Clinical Leadership Team.

• Lead and coach QA Heads and sub-functions across four international sites.

• Define, harmonize, and implement global quality policies, standards and procedures, aligned with cGMP, internal requirements, and client expectations.

• Champion a solid Quality Culture across clinical, packaging and operational activities.

• Collaborate cross-functionally with Technical, Operations, Engineering, Business Development and Supply Chain.

• Oversee the Pharmaceutical Quality System (PQS) and drive continuous improvement.

• Optimize quality systems, clarify roles and structure of local QA teams.

• Supervise batch record review, validation activities (equipment, cleaning, CSV), and key compliance processes.

• Lead audits (client, supplier, agency) and manage regulatory filings as needed.

• Handle customer escalations and lead global management review processes.

• Stay up to date with regulatory trends and represent the company toward health authorities, clients, and suppliers.

• Manage the quality budget and contribute to strategic planning at global level.

  • Travel across Europe and th e US when required.

Profile

• Master’s degree minimum, ideally in Pharmacy, Life Sciences or related field.

• Additional certifications in QA/RA or GxP are a strong asset.

• 15+ years experience in senior QA/RA roles in the pharmaceutical sector.

• Proven track record managing international, multi-site quality teams.

• Deep knowledge of GxP, quality systems, validation and regulatory requirements.

• Fluent in English (Dutch is an asset).

• Strategic mindset with strong operational leadership and hands-on spirit.

• Excellent communication, influencing and change management skills.

• Willingness to travel internationally.

Benefits

• A technical and modern environment with a strong focus on quality and innovation.

• The ability to have a significant global impact across multiple sites and business units.

• A culture encouraging collaboration, ownership and continuous improvement.

• Competitive salary package with full benefits.

Interested?

Send your application or request more information at:
giulio.monaco@key4nova.com