Overview
Quality Control Lead Jobs in European Union at Mackenzie Stuart
Title: Quality Control Lead
Company: Mackenzie Stuart
Location: European Union
Quality Control Manager – EU – Global Animal Health Company
MUST HAVE PHARMA OR ANIMAL HEALTH EXPERIENCE
Mackenzie Stuart are working exclusively with a global animal health company in search for a Quality Control Manager to lead the development, implementation, and validation of various assays in relation to the vaccine and pharmaceutical portfolio.
Key Responsibilities:
Collaborate with R&D and Regulatory Affairs to determine tasks and resources essential for achieving project milestones.
Design and oversee laboratory experiments, analytical method development, validation, and transfer in partnership with R&D, clinical operations, and manufacturing teams.
Ensure compliance with national and international regulations and standards.
Support internal and external inspections and audits.
Proactively identify and mitigate risks to QC processes while maintaining and improving validated test methods.
Align QC activities and timelines with regulatory requirements and project goals.
Implement validated QC methods across all manufacturing sites.
Draft and coordinate the review of protocols, method designs, monitoring plans, and validation reports.
Resolve technical challenges and communicate experimental results to facilitate informed decision-making on process design.
Prepare relevant sections of registration dossiers in collaboration with R&D and Regulatory Affairs for product license applications.
Contribute to budget development and management activities.
Stay informed on the latest trends in the life sciences and pharmaceutical industry.
Basic Qualifications:
MS or PhD in Biology, Biotechnology, Chemistry, Medicine, or a related field.
4-8 years of experience with MS; 2-5 years with PhD.
Proven expertise in analytical, microbiological, and veterinary quality control testing, assay validation, and stability studies.
Familiarity with cGxP in pharmaceutical manufacturing.
Knowledge of EMA regulations and ICH guidelines.
Excellent teamwork, communication, decision-making, and organizational skills.
Proficiency in Microsoft Word, PowerPoint, and Excel.
