Covance

QA Manager - GLP/GCP

Job Location(s) SG-Singapore
Job Number
2022-80254
Job Category
Quality Assurance
Position Type
Full-Time
Telecommute
No

Job Overview

Essential Job Duties: 
- Plans and executes the necessary QA inspection programs to maintain local GLP/GCP compliance
- Develops procedures as necessary to cover site GLP/GCP needs
- Ensures recruitment and training of a competent and sufficient GLP/GCP QA workforce to meet business site needs
- Accountable for budgetary oversight of the GLP/GCP QA team
- Leads site communications with external Regulatory and Client compliance counterparts
- Ensure the consistent implementation, use and review of SOPs
- Escalate issues to management in a timely manner, implementing appropriate solutions including preventative actions
- Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
- Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
- Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
- Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
- Interpret applicable quality regulations/standards and create appropriate policies and procedures Lead interactions with clients or regulatory agencies
- Recruit, train, coach and develop individuals based on their development or business needs
- Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) management
responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties, as assigned by management

Education/Qualifications

Recommended:
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education

Experience

Minimum Required:
- 8 years in regulatory environment (experience in GXP roles)
- Experience & regulatory expertise of industry quality systems/standards
- Ability to interpret applicable regulations/standards
- Experience in leading process improvement initiatives
- Ability to communicate and negotiate internal stakeholders effectively
- Ability to supervise resources in a single geographic location

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