Senior Quality Assurance Manager
Key Responsibilities
* Ensure analytical activities are executed on-time and to high-quality standards, in compliance with our site's Quality Management Systems (QMS) and current Good Manufacturing Practices (cGMP).
* Lead the quality control team in meeting customer expectations and needs.
* Investigate laboratory anomalies and implement corrective actions to prevent future occurrences.
* Review and approve quality events, including deviations, CAPAs, and OOX results.
* Promote efficient QC processes, reducing errors and increasing productivity.
* Mentor and develop a strong Quality Control team, ensuring they have the necessary training to perform their duties effectively.
* Represent the quality control department during client visits, audits, and regulatory inspections.
* Plan and manage medium- and long-term equipment and personnel needs for the QC laboratory.
About the Role
This is a strategic leadership position that requires a seasoned professional with a strong background in quality assurance and laboratory management. The successful candidate will be responsible for leading a team of quality control professionals and ensuring that all analytical activities are executed to the highest standards.
The ideal candidate will possess excellent leadership and communication skills, as well as a deep understanding of quality management systems and cGMP regulations. They will be able to work effectively in a fast-paced environment and make decisions based on data-driven analysis.
Requirements
* A bachelor's degree in chemistry, biochemistry, biology, or a related field.
* At least 10 years of experience in quality assurance and laboratory management, preferably in a pharmaceutical or biotechnology setting.
* Familiarity with electronic data lifecycle management and method transfer/validation.
* Strong knowledge of cGMP regulations and quality management systems.
* Excellent leadership and communication skills.
Qualifications
The successful candidate will possess the following qualifications:
* University studies in chemistry, biochemistry, biology, or pharmacy or equivalent.
* >10 years' experience in QC laboratory management, CMO advantageous.
* Fluent in English.
* Autonomous and aptitude to work on the ground.
* Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer analysis, etc.
* Knowledge of electronic data lifecycle management in the laboratory to ensure data reliability and integrity.
* Familiar with method transfer and validation of drug products, material and product release as well as stability studies of drugs under different conditions.
* Familiar with laboratory investigation and establishment of corrective and preventive measures.
* Strong working knowledge to ensure quality control compliance with applicable regulations i.e. cGMP.
* Organized and rigorous, able to provide leadership and coaching to the QC team in order to maintain an environment of trust and personal accountability.
* Demonstrate ability to effectively communicate with the team and all levels of the organization. Work as a strong team partner in the site.
* Use of scientific risk assessment based on sufficient data to reduce and control the risk of late-stage commercialization project operations. Ability to make decision.
* Able to manage, track and record.