QC Manager - Chemistry Lab

• Promote a safety-first culture throughout the facility.
• Collaborate with the Quality Director and cross functionally each department along with site leadership to improve QC laboratory quality culture.
• Lead QC laboratory budget and initiate cost control measures.
• Ensure comprehensive training 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 of Raw materials, Drug substance, Packaging materials, Drug product and other utilities samples. Project delivery of method transfer and validation as a part of technology transfer.
• Ensure strict adherence to cGMP, various regulatory like HSA, FDA and EU and company guidelines and regulations.
• Review and Approve the QC all documents like specification methods and other protocols.
• Identify and address gaps in lab management and operations when regulations and pharmacopoeia update.
• Lead timely resolution of laboratory investigations and deviations.
• Report quality metrics and schedules projects to meet timelines.
• Implement data integrity principles throughout QC processes.
• Hire, develop, and lead QC Chemistry professionals. Further team growth and address performance issues.
• Mentor and empower team members to achieve functional objectives.

Experience

• 5-years in a leadership role in QC Lab
• University degree in chemistry, biochemistry, or life sciences with shown experience in a pharmaceutical QC lab.
• Proficient with regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.

Proficiencies

• 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.