Manager, Regulatory

1 week ago

Singapore Brenntag Full time

Position Summary

The Regulatory & Quality Manager is responsible for establishing and enforcing policies to ensure the Company complies with industry regulations and laws applicable to its businesses.

Responsibilities and Duties
- Establish and enforce policies to ensure compliance with corporate quality policies, industry regulations, and applicable laws, including GxP standards (e.g., Good Manufacturing Practice [GMP], Good Distribution Practice [GDP]).
- Manage overall quality within the Company to ensure activities adhere to regulatory requirements and corporate standards.
- Design, develop, and implement the Company’s quality management systems, ensuring maintenance at all levels.
- Develop and implement precise methodologies for validation to comply with applicable regulations. Lead validation and qualification projects and processes.
- Oversee internal and external audits, ensuring timely closure of findings. Provide monthly KPIs and status reports on quality initiatives to Management.
- Investigate non-conformities in management systems and follow up on corrective and preventive actions.
- Stay updated on industry changes, trends, and best practices, assessing their impact on organizational processes.
- Recommend improvements to management systems.
- Develop and conduct quality training programs.
- Ensure compliance with management system practices.
- Assist RA leadership in conducting risk assessments to identify hazards and implement effective control measures.
- Ensure safety measures for machinery, equipment, or processes are adequately implemented.
- Adhere to company procedures, safety rules, and measures stated in the WSH Risk Assessment.
- Avoid unsafe or negligent acts that could endanger yourself or others.
- Promote environmental protection, pollution prevention, and compliance with sustainable practices as identified in policy statements.
- Ensure staff performing duties with significant environmental impact are competent through appropriate training, instruction, or experience.
- Perform other duties as assigned.
- Authority
- Place activities on hold for non-conformity until deficiencies are corrected.
- Approve claims for immediate staff in accordance with policies.
- Conduct performance reviews for immediate staff and recommend promotions.
- Manage counseling and disciplinary actions, including termination/dismissal, in consultation with the immediate superior and HR.
- Conduct interviews and selection processes, including offers of employment (reviewed with HR) for Executive Level and below.
- Knowledge and Skills Requirements
- Degree in Quality Management or equivalent.
- At least 4-5 years of GMP and GDP-related experience.
- Strong knowledge of industry rules and regulations.
- Demonstrated leadership abilities.
- Excellent analytical and troubleshooting skills.
- Strong problem-solving skills with the ability to provide prompt resolutions.
- Good coordination and organizational skills.
- Strong verbal and written communication skills.
- Ability to supervise, delegate tasks, and evaluate subordinate performance effectively.
- Proficiency in Microsoft Office.
- General
- Abide by the Company's policies and procedures at all times.
- Represent the Company in a professional manner.
- Maintain confidentiality of the Company's information.

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