Regulatory Compliance Officer

3 weeks ago


Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time
Job Overview

We are seeking an experienced Regulatory Compliance Officer to join our Quality Control team at WUXI XDC SINGAPORE PRIVATE LIMITED in Tuas Biomedical Park. As a key member of the team, you will be responsible for ensuring compliance with internal and external requirements via end-to-end quality control system oversight.

About the Role

In this role, you will oversee the routine operation of the QC lab, including managing the QC team to ensure delivery at the right quality, cost, and speed. You will lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight. Your responsibilities will include ensuring all activities in the QC team are performed with compliance of cGMP, data integrity, and EHS requirements.

Key Responsibilities

* Manage the routine operation of the QC team to ensure delivery at the right quality, cost, and speed.
* Lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight.
* Ensure all activities in the QC team are performed with compliance of cGMP, data integrity, and EHS requirements.
* Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions.
* Oversight of the training, evaluation, and management of staff in the QC lab. Coaching, developing, and supporting them in reaching their full potential.
* Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.

Requirements

To be successful in this role, you will need:

* A Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry, or other related disciplines.
* Minimum 7 years of experience in the biotech or biopharma industry.
* A good understanding of the overall view of the drug development process.
* A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset.
* Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias.
* Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing.

What We Offer

We offer a competitive salary package of SGD 150,000 per annum, comprehensive benefits, and opportunities for growth and development. If you are a motivated and experienced professional looking for a new challenge, please apply now

Estimated Salary: SGD 150,000 per annum

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