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.
o 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
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