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Director of Quality Control

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Deel deze vacature

For our client, a global biopharmaceutical manufacturer recognised for its leadership in large molecule medicines, we're looking to recruit a Director Quality Control to lead and elevate the Quality Control organisation supporting a complex biologics manufacturing network. This position is specifically interesting as you will take ownership of a strategically critical QC function, with the mandate and autonomy to shape its direction, systems and people at director level.

Details

Pharmaceutical

Quality/RA

Leiden - Netherlands

40 uur per week

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Zo maak jij het verschil

You'll lead the Quality Control organisation for a site producing Intermediates, API and Drug Products within a Large Molecule platform, covering both internal manufacturing and external third-party partners. You'll be the accountable quality leader for the department, translating regulatory and corporate standards into day-to-day laboratory practice, while building a team capable of sustaining that standard over time. 
  • Full quality accountability for the Site Quality Control department, including release, stability, raw material,microbiological and environmental testing;
  • System Owner for Laboratory Controls;
  • Ensure compliance with GMP, EHS and SOX requirements across all QC activities;
  • Ensure full alignment of Site Quality Control with registered dossiers for Large Molecule products;
  • Provide governance to Large Molecule stability programs across all development phases;
  • Manage testing and release lead times to secure timely product disposition;
  • Hold budget responsibility for CAPEX, headcount, CIP and departmental expenses;
  • Act as the department's spokesperson during regulatory audits and inspections. 

QTC logo icon Wat nodig is

Wat jij mee brengt

This role calls for a scientifically grounded leader who combines technical depth in analytical and quality systems with the people-leadership skills to run a sizeable laboratory organisation. You're comfortable operating at the intersection of regulatory rigour and operational pragmatism, and you know how to translate both into a high-performing team.
  • Master's degree in a scientific or technical discipline;
  • 10-15 years' experience in a senior leadership role within the biological and/or pharmaceutical industry;
  • Proven experience managing people and building laboratory or quality teams;
  • Working knowledge of FDA/EMA regulatory frameworks and GMP requirements applicable to biologics;
  • Experience supporting an adjacent functional area (e.g. R&D, Manufacturing, Engineering, EHS or Technical Services) is a plus;
  • Strong written and verbal communication skills, with a collaborative, open leadership style;
  • Fluent in English;
  • Demonstrated strategic thinking, with the ability to define and drive a vision for the function.

QTC logo icon Wat wij bieden

Jouw voordelen

Beyond the base package, you'll join an organisation that invests structurally in the people who run its quality systems, with the scope to shape a function that sits at the core of the business.
  • A director-level role with full ownership of a Quality Control organisation;
  • A competitive base salary complemented by an annual bonus tied to individual and company performance;
  • Generous vacation entitlement and parental leave of at least 12 weeks;
  • Bereavement, caregiver and volunteer leave;
  • Well-being reimbursement and programs supporting financial, physical and mental health;
  • Service anniversary and recognition awards;
  • Participation in company insurance plans, subject to plan terms;
  • A genuinely strategic mandate, with direct visibility to senior site and quality leadership.

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