Quality Assurance & Compliance, Supervisor

Position Overview

Spimaco Addwaeih, a leading pharmaceutical company based in Dammam, is seeking a highly motivated and detail-oriented Quality Assurance & Compliance Supervisor to join our dynamic team. In this pivotal role, you will oversee and ensure adherence to stringent regulatory standards, maintain compliance with local and international guidelines, and uphold the highest levels of product quality and safety. Your leadership will be instrumental in driving operational excellence, fostering a culture of continuous improvement, and supporting the company’s commitment to delivering safe, effective, and reliable pharmaceutical products to patients worldwide.

Key Responsibilities

• Regulatory Compliance Oversight: Monitor and enforce compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements, including those set by the Saudi Food and Drug Authority (SFDA) and international bodies such as the FDA and EMA.
• Quality Assurance Leadership: Supervise a team of quality assurance professionals to ensure that all processes, documentation, and procedures align with regulatory standards and company policies. Provide guidance, training, and performance evaluations to foster a high-performing team.
• Audit and Inspection Management: Coordinate and participate in internal and external audits, including supplier audits, customer audits, and regulatory inspections. Address findings promptly and implement corrective and preventive actions (CAPAs) to mitigate risks and enhance compliance.
• Documentation and Record Keeping: Oversee the maintenance of accurate and up-to-date documentation, including standard operating procedures (SOPs), batch records, and compliance reports. Ensure all records are complete, legible, and readily available for review.
• Risk Assessment and Management: Identify potential risks in manufacturing and quality processes, conduct risk assessments, and develop mitigation strategies to prevent deviations and non-conformances. Collaborate with cross-functional teams to implement robust quality controls.
• Training and Development: Develop and deliver training programs to enhance the technical skills and regulatory knowledge of employees. Ensure that all staff are aware of their roles and responsibilities in maintaining compliance and product quality.
• Continuous Improvement Initiatives: Lead continuous improvement projects to optimize quality systems, reduce waste, and enhance efficiency. Utilize data-driven approaches to identify trends, implement best practices, and drive operational excellence.

Qualifications and Skills

To excel in this role, you must possess the following qualifications and competencies:

• Education: A bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field. A master’s degree or professional certification in Quality Assurance, Regulatory Affairs, or a similar discipline is highly desirable.
• Experience: Minimum of 5 years of progressive experience in quality assurance, compliance, or regulatory affairs within the pharmaceutical or healthcare industry. Prior supervisory or team leadership experience is essential.
• Technical Knowledge: In-depth understanding of GMP, GLP, ICH guidelines, and other regulatory frameworks. Familiarity with quality management systems (QMS) and software tools used in compliance tracking and documentation.
• Analytical Skills: Strong problem-solving abilities with a keen eye for detail. Proficiency in conducting root cause analyses, risk assessments, and CAPA management.
• Communication and Leadership: Excellent verbal and written communication skills in English and Arabic. Ability to lead and mentor a team, collaborate with stakeholders, and present findings to senior management and regulatory authorities.
• Regulatory Acumen: Up-to-date knowledge of local and international regulatory requirements, including SFDA, FDA, EMA, and other relevant agencies. Experience with regulatory submissions and inspections is a plus.

Work Environment and Benefits

Spimaco Addwaeih offers a competitive compensation package, including a comprehensive benefits program, professional development opportunities, and a collaborative work environment in Dammam. As a Quality Assurance & Compliance Supervisor, you will play a critical role in safeguarding public health while advancing your career in a dynamic and rewarding industry.