Overview
Head of Quality Control Jobs in Barcelona, Catalonia, Spain at AL Solutions
Title: Head of Quality Control
Company: AL Solutions
Location: Barcelona, Catalonia, Spain
Position Summary:
The Head of Quality Control (QC) is responsible for leading and managing the Quality Control function within the organization, ensuring compliance with cGMP, ICH, FDA, EMA, and other applicable regulatory guidelines. This role involves overseeing analytical testing, stability programs, raw material testing, in-process controls, and finished product release while ensuring the highest quality standards are met.
Key Responsibilities:
Lead and oversee the Quality Control department, including analytical chemistry, microbiology, and raw material testing teams.
Develop and implement robust QC strategies, policies, and procedures aligned with regulatory requirements and business goals.
Ensure compliance with cGMP, FDA, EMA, ICH, and other global regulatory requirements.
Manage QC laboratory operations, including equipment qualification, method validation, and technology transfers.
Oversee stability studies, release testing, and in-process quality control for small molecule drug substances and drug products.
Collaborate with cross-functional teams, including Quality Assurance (QA), Manufacturing, R&D, and Regulatory Affairs, to support product development and commercialization.
Lead investigations related to out-of-specification (OOS) results, deviations, CAPAs, and laboratory incidents.
Drive continuous improvement initiatives in QC operations, ensuring efficiency, cost-effectiveness, and adherence to best practices.
Prepare for and support regulatory inspections and client audits, ensuring readiness and compliance.
Develop and mentor the QC team, fostering a culture of quality excellence, scientific integrity, and continuous learning.
Qualifications & Experience:
Advanced degree (MSc or PhD) in Chemistry, Pharmaceutical Sciences, or a related field.
10+ years of experience in Quality Control within the pharmaceutical or CDMO industry, with a focus on small molecules.
Strong knowledge of analytical techniques, including HPLC, GC, MS, spectroscopy, and wet chemistry.
Experience with method development, validation, and technology transfer.
Demonstrated leadership experience, including managing teams and laboratory operations.
Expertise in regulatory compliance, cGMP, ICH guidelines, and FDA/EMA regulations.
Strong problem-solving, organizational, and communication skills.
Experience in leading regulatory inspections and client audits.
Ability to work in a fast-paced, dynamic environment with cross-functional teams.
