I am working with a leading Contract Development and Manufacturing Organization (CDMO) specializing in pharmaceutical and biopharmaceutical products. With a strong presence in Europe and a commitment to excellence, we partner with global clients to deliver high-quality drug development and manufacturing services. Our Barcelona site is growing, and we are seeking a dynamic and experienced Head of Quality Control to lead our QC department.
Job Summary
As the Head of Quality Control, you will be responsible for leading and managing all QC operations at the site. You will oversee analytical testing, method validation, stability programs, raw material testing, and support for manufacturing activities. Your leadership will ensure the lab operates in compliance with GMP, regulatory expectations, and company quality standards.
Key Responsibilities
* Lead and develop the Quality Control department, including analytical chemistry, microbiology, stability, and raw material labs.
* Oversee the planning and execution of QC testing for raw materials, intermediates, APIs, and finished products.
* Ensure timely and accurate analytical support to manufacturing, development, and release processes.
* Manage the qualification, calibration, and maintenance of laboratory equipment.
* Ensure compliance with GMP, ICH, and other regulatory guidelines.
* Support regulatory inspections and client audits; lead QC responses and corrective action plans.
* Collaborate with QA, Production, Regulatory Affairs, and R&D teams to ensure cross-functional alignment.
* Oversee method development, transfer, and validation processes.
* Develop and manage QC budgets, resources, and training programs.
* Implement and monitor KPIs to drive efficiency and continuous improvement within the QC function.
* Ensure the integrity of data and enforce ALCOA+ principles in the laboratory.
Requirements
Education:
* Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biochemistry, or a related scientific discipline.
* PhD is a plus.
Experience:
* Minimum 8–10 years of experience in Quality Control in the pharmaceutical/biotech industry, with at least 3–5 years in a leadership role.
* Experience within a CDMO environment strongly preferred.
* In-depth understanding of GMP regulations (EU/FDA), analytical techniques, and regulatory compliance.
Skills:
* Strong leadership and people management skills.
* Strategic thinker with excellent organizational and communication abilities.
* Fluency in English is required; Spanish and/or Catalan is a plus.
* Proficiency in LIMS, chromatography software, and common QC systems.