Role Summary
As Head of Quality, based in Liège, Belgium, you will report directly to the CEO and hold overall responsibility for the leadership, management, and continuous improvement of the site Quality Management System. You will lead Quality Assurance activities across the site, including oversight of outsourced QC activities, and ensure compliance with EU GMP, ICH guidelines, customer requirements, and other applicable regulatory expectations. You will also work hand in hand with the site's Qualified Person (QP) to ensure strong alignment on quality oversight and compliance‑related decisions.
This is a senior role for a seasoned quality professional who combines strategic thinking with hands‑on execution. In a small CDMO environment, you will be expected to take ownership of both high‑level quality decisions and detailed QA activities, while working closely with Manufacturing, Engineering, IT, external partners, clients, and regulatory authorities.
Roles and Responsibilities
You will:
Maintain, manage, and further develop the site Quality Management System in line with EU GMP, ICH guidelines, and other applicable regulatory requirements.
Lead and contribute to management review activities, ensuring that quality performance, compliance status, audit outcomes, CAPA effectiveness, and quality risk assessments are reviewed and escalated appropriately.
Act as the primary quality representative during regulatory inspections and client audits.
Provide hands‑on oversight and execution of core QA activities, including deviation management, complaint management, CAPA management, change control assessment and approval, OOS/OOT oversight, investigations, and quality risk management.
Support batch record review activities and ensure appropriate quality oversight of batch‑related documentation.
Review, support, and approve procedural documents and other GMP documentation.
Support and approve validation and qualification activities and documentation, including computerized systems.
Support and approve maintenance and calibration activities and associated documentation where quality approval is required.
Ensure effective qualification, oversight, and performance monitoring of suppliers and outsourced activities.
Maintain and manage the audit program and quality agreements for suppliers and outsourced partners.
Review and approve outsourced activity results, investigations, changes, and supplier change notifications.
Lead and develop the Quality team while fostering a strong quality culture across the organization.
Provide GMP and quality guidance to Manufacturing, Engineering, and IT.
Support client interactions on quality‑related matters, including technical discussions and project oversight.
Define and implement the site quality strategy in alignment with business objectives and growth plans.
Support new product introductions, scale‑up activities, and new technology implementation from a quality perspective.
Identify, assess, and mitigate quality and compliance risks proactively.
Ideal Candidate Profile
We are looking for someone who combines strategic quality leadership with hands‑on operational ownership in a GMP‑regulated sterile manufacturing environment .
Education: University degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
Experience: 8‑10 years of experience in the pharmaceutical industry, including significant exposure to sterile manufacturing.
Leadership background: Minimum 3 years in a QA management or senior leadership role within a GMP‑regulated environment.
Outsourced activities: Demonstrated experience managing and overseeing suppliers and outsourced activities.
Regulatory expertise: Strong knowledge of EU GMP, ICH guidelines, and aseptic processing requirements.
Inspection readiness: Experience interacting with regulatory authorities and hosting client audits.
Technical understanding: Solid understanding of validation, qualification, contamination control strategies, and quality oversight of computerized systems.
Qualified Person status: Eligibility to act as a Qualified Person under EU regulations is not mandatory, but would be considered a strong asset in case of absence of the principal QP.
Digital proficiency: Comfortable working with digital quality systems, structured documentation, and new software tools in a paperless environment.
AI & automation mindset: Open to working with AI‑assisted tools, automated systems, and modern digital processes, while actively promoting and supporting their development and continuous improvement to strengthen quality oversight, documentation workflows, and operational efficiency.
Communication: Excellent written and verbal communication skills, with the ability to interact effectively with clients, regulators, and cross‑functional internal teams.
Working style: Structured, pragmatic, solution‑oriented, and able to work effectively in a small organization with limited resources and high accountability.
Judgment and influence: Strong decision‑making capability, sound quality judgment, and the ability to guide the business while maintaining compliance standards.
What We Offer
At White Raven, we embrace the vibrant and energizing spirit of a start‑up work environment. Our culture fosters creativity, innovation, and collaboration, and we value the ideas and contributions of every team member. We believe in maintaining a balanced and stimulating environment that supports learning, ownership, and rapid evolution.
As part of our team, you will have the opportunity to shape the quality strategy and Quality Management System of a growing sterile manufacturing site. You will work on exciting and high‑impact projects in an environment where technology, automation, artificial intelligence, digital systems, and continuous improvement play a central role.
We cherish our diverse and inclusive atmosphere and strive to ensure every individual feels welcome, comfortable, and empowered to perform at their best. In essence, we combine the agility, passion, and curiosity of a start‑up with the ambition to make significant contributions to the pharmaceutical and biotech industry.
Data Privacy Notice
By submitting your application, you consent to White Raven processing your personal data for recruitment purposes. Your information will be handled in accordance with applicable data protection regulations and will only be used for evaluating your candidacy. We retain applicant data for a maximum of 12 months, after which it will be securely deleted unless you provide consent for longer retention.
#J-18808-Ljbffr