QC Manager - Chemistry Lab

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Job Description

Position Summary

The QC Chemistry Laboratory Manager is leading all aspects of the quality control (QC) operations within the laboratory. This role ensures that all activities align with regulatory standards and company policies, and ensure the on-time results meet the cGMP regulations. Ensure that Quality control operations meet cGMP and Regulatory compliance and Data integrity principles while respecting regulations, corporate standards, and clients’ requirements.

Responsibilities

1. Promote a safety-first culture throughout the facility.
2. Collaborate with the Quality Director and cross-functionally with each department along with site leadership to improve QC laboratory quality culture.
3. Lead QC laboratory budget and initiate cost control measures.
4. Ensure comprehensive training for staff, covering skills, analyst qualification, cGMP, and safety.
5. Lead internal audits, data integrity surveillance, regulatory inspections, and customer audits.
6. 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.
7. Ensure strict adherence to cGMP, various regulations like HSA, FDA, and EU, and company guidelines and regulations.
8. Review and approve all QC documents like specification methods and other protocols.
9. Identify and address gaps in lab management and operations when regulations and pharmacopoeia update.
10. Lead timely resolution of laboratory investigations and deviations.
11. Report quality metrics and schedule projects to meet timelines.
12. Implement data integrity principles throughout QC processes.
13. Hire, develop, and lead QC Chemistry professionals. Further team growth and address performance issues.
14. Mentor and empower team members to achieve functional objectives.

Experience

1. 5 years in a leadership role in QC Lab.
2. University degree in chemistry, biochemistry, or life sciences with shown experience in a pharmaceutical QC lab.
3. Proficient with regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.
4. Strong technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.).
5. Expertise in analytical method validation and transfer as per Pharmacopoeia.
6. Familiarity with testing protocols, analytical instrumentation, and sterile manufacturing and biologic-specific methodologies.
7. Excellent interpersonal and communication skills in English.
8. Effective cross-functional partnership within the organization.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.