JOB OVERVIEW
The Quality Management & Regulatory Supervisor ensures the company complies with applicable regulatory requirements and maintains strong quality standards across operations. This role leads the implementation and upkeep of the Quality Management System (QMS), drives continuous improvement, and supports product and business compliance through audits, documentation, and coordination with internal teams and regulators.
JOB RESPONSIBILITIES
Quality Management System (QMS)
- Establish, implement, and maintain the company's QMS aligned with ISO 9001:2015 and applicable pharma standards.
- Develop and improve quality policies, SOPs, work instructions, and quality records across departments.
- Ensure consistent implementation of quality assurance protocols company-wide.
Compliance
- Ensure compliance with relevant regulations and industry requirements (e.g., FDA/DOH rules applicable to operations).
- Prepare, maintain, and control regulatory and quality documents needed for licenses, permits, and renewals.
- Coordinate with regulatory bodies and support inspections, audits, and compliance submissions.
Good Storage Distribution Practices
- Ensure compliance with Good Storage Distribution Practices (GSDP) and related standards in warehousing, handling, storage, and distribution.
- Conduct routine quality checks and site assessments to confirm adherence to SOPs and handling requirements.
- Drive corrective actions for deviations and prevent recurrence.
Audits and Continuous Improvement
- Plan and conduct internal audits; support external audits and customer/regulatory audits.
- Lead investigations of non-conformities and deviations; implement and track CAPA (Corrective and Preventive Actions).
- Monitor quality KPIs and prepare management reports with findings and recommendations.
Qualifications
- Bachelor's Degree in Pharmacy
- Licensed Pharmacist
- At least 2–5 years experience in Quality Assurance and/or Regulatory Affairs
- Knowledgeable in Good Distribution Practices and ISO 9001:2015
- Strong communication and interpersonal skills
- Detail-oriented, organized, and able to manage multiple deadlines
