Job Title:
QC Chemistry Laboratory Manager
This role oversees all aspects of quality control (QC) operations within the laboratory, ensuring compliance with regulatory standards and company policies.
About the Role
We are seeking an experienced leader to manage our QC chemistry laboratory. The successful candidate will be responsible for leading a team of professionals and overseeing all aspects of quality control operations.
Main Responsibilities
* Promote a culture of safety throughout the facility.
* Collaborate with cross-functional teams to improve laboratory quality culture.
* Lead the QC laboratory budget and implement cost-saving measures.
* Develop comprehensive training programs for staff, covering skills, analyst qualification, cGMP, and safety.
* Lead internal audits, data integrity surveillance, regulatory inspections, and customer audits.
* Coordinate timely and approved testing processes for raw materials, drug substance, packaging materials, drug product, and other utilities samples.
* Ensure strict adherence to cGMP, various regulatory requirements, and company guidelines.
* Review and approve QC documents, such as specifications, methods, and protocols.
* Identify and address gaps in lab management and operations due to regulations and pharmacopoeia updates.
* Lead timely resolution of laboratory investigations and deviations.
* Report quality metrics and project schedules to meet timelines.
* Implement data integrity principles throughout QC processes.
* Hire, develop, and lead QC chemistry professionals to drive team growth and address performance issues.
Requirements
* 5 years of experience in a leadership role in a QC laboratory.
* University degree in chemistry, biochemistry, or life sciences, with demonstrated experience in a pharmaceutical QC laboratory.
* Proficiency in regulatory expectations, including PICS, ICH, Singapore HSA, EMA, and US FDA.
Preferred Qualifications
* Strong technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.).
* Expertise in analytical method validation and transfer as per Pharmacopoeia.
* Familiarity with testing protocols, analytical instrumentation, and sterile manufacturing and biologic-specific methodologies.
* Excellent interpersonal and communication skills in English.
* Effective cross-functional partnership within the organization.