Qc - Tech Services Manager

2 weeks ago

Singapore Thermo Fisher Scientific Full time

**JOB SUMMARY**:
This position is expected to be QC Technical Service Lead, under QC Head’s leadership, Delivers analytical solution to clients through expertise in biologic specific method qualification and validation strategies while ensuring on-time delivery for projects as well as overseeing, the group activities of instrument qualification, PM and calibration, Stability program, specifications management and working with the laboratories to schedule all types of sample testing.

**RESPONSIBILITIES**:

- Ensure the safety message that the first goal of all employees is safety is implemented and lived throughout their organization and bolster this throughout the facility as possible.
- Hires, develops, and manages professionals within the Quality Control Technical Services. Provides feedback and coaching, provides opportunities for growth and takes necessary disciplinary actions. Ensures awareness and compliance with Health authority regulations.
- Coordinate/drive customer specific projects within functional area and assigns resources as appropriate. Interfaces with customers to ensure clear and open communication is maintained. Responsible for the capacity forecast model for human and equipment resources and represents the Quality Control organization at site / planning meetings.
- Work with Quality Control Sr. Manager and Quality Leadership to continually seek ways to improve the Quality Culture of the organization and specifically of the Quality Control organization. Approves department budget and initiates cost control measures.
- Ensures adequate training (skills-based, cGMP and Safety) of personnel within department, to support various phases of production both clinical and commercial through highly competent staff.
- Reviews departmental documentation (e.g., Standard Operating Procedures, STPs, Qualification protocols, Specifications etc.). Participates in revisions, providing input, as necessary.
- Make sure all necessary reagents, standard references etc. that support testing are well planned, maintained and supplied as business needs required;
- Ensure materials are sampled accroding to production schedule in compliant way as per cGMP requirement and global quality standard;
- Manage stability system and program to ensure all stability programs are executed in a timely manner as planned and provide data analysis and stability report as required as per cGMP requirement.
- Report appropriate metrics to ensure timelines and turnaround time are on track.
- Work with group leads to set milestone deliveries and ensure adherence to commitments.

**REQUIREMENT**

**Education**:

- Bachelor’s Degree in Life Sciences

**Experience**:

- 6 years of experience in a regulated manufacturing, Quality or QC laboratory environment
- 4 years prior supervisory or management experience required.

**Competencies**:

- Extensive knowledge and exposure to cGMP environment. Audit experience.
- Extensive knowledge of general and specific QC testing principles, as applicable to focus of position (e.g., chemistry, microbiology, biochemistry, bio-assay, etc.).
- Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation including biologic specific methodology.
- Strong interpersonal and communications skills; written and oral.
- Solid understanding of applicable regulatory requirements as it relates to analytical method transfer, microbiological verification, USP, and stability
- Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA
- Communicate effectively to peers and all levels of the organization within and outside of department. Interact with external contacts.
- Ability to work cross functionally with members of Quality Control, Operations, and Biologics to meet timelines and objectives in a compliant manner
- Delegates and/or participates in Health Agency/internal audits.

**Languages**:

- Chinese and English

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