Description: QC Head – CDMO (Barcelona)
Position: QC Head
Location: Barcelona, Spain
Company: Leading Contract Development and Manufacturing Organization (CDMO)
About the Role We are seeking an experienced and dynamic QC Head to lead our Quality Control operations at a state-of-the-art CDMO facility in Barcelona.
The QC Head will be responsible for ensuring all analytical testing, quality systems, and regulatory compliance meet the highest industry standards.
This pivotal role involves close collaboration with internal teams, clients, and regulatory bodies to drive quality excellence in support of pharmaceutical and biopharmaceutical product development and manufacturing.
Key Responsibilities Leadership & Team Management:Lead and manage the Quality Control (QC) team, ensuring appropriate staffing, training, and professional development.Foster a culture of quality, collaboration, and continuous improvement across the QC department.Analytical Testing Oversight:Oversee all analytical testing activities, including raw materials, in-process controls, finished products, and stability studies.Ensure compliance with pharmacopeial, client-specific, and regulatory requirements.Quality Systems Management:Develop, implement, and maintain robust QC processes, SOPs, and protocols in alignment with GMP and ICH guidelines.Ensure timely investigation and resolution of OOS, OOT, and deviations related to QC activities.Compliance & Regulatory Readiness:Serve as the key point of contact during audits and inspections by regulatory authorities and clients.Maintain inspection readiness and implement corrective and preventive actions (CAPAs) as required.Cross-Functional Collaboration:Work closely with R&D, Production, QA, and Project Management teams to ensure seamless technology transfer and process validation.Partner with clients to address quality-related concerns and meet project milestones.Performance Monitoring:Define and monitor KPIs for QC processes and activities to ensure efficiency and effectiveness.Implement continuous improvement initiatives to enhance lab operations and data integrity.Qualifications & Experience Educational Background:Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmacy, or a related field.
A Ph.D. is a plus.Experience:Minimum 10 years of experience in Quality Control within the pharmaceutical or biopharmaceutical industry.At least 5 years in a leadership role, preferably in a CDMO or similar fast-paced environment.Technical Expertise:In-depth knowledge of analytical techniques (HPLC, GC, spectrophotometry, etc.)
and microbiological testing.Strong understanding of GMP, ICH guidelines, and global regulatory requirements (FDA, EMA, etc.
).Skills:Excellent leadership, organizational, and communication skills.Ability to manage multiple projects and priorities in a deadline-driven environment.Proficient in quality management systems (e.g., LIMS, TrackWise).Languages:Fluency in English is mandatory.
Proficiency in Spanish is highly desirable.