Provide strategic leadership and direction to all departments within the pharmaceutical site, including production, quality control, regulatory affairs, and logistics.
Foster a culture of excellence, teamwork, and continuous improvement throughout the organization.
Lead and mentor departmental managers and supervisors to optimize performance and achieve organizational goals.
Oversee all aspects of pharmaceutical manufacturing operations, including production scheduling, resource allocation, and capacity planning.
Monitor production processes to ensure adherence to quality standards, regulatory requirements, and production schedules.
Implement efficient workflows and process improvements to enhance productivity and reduce costs.
Ensure compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant quality standards.
Develop and maintain quality systems, procedures, and documentation to support regulatory compliance and product quality.
Lead investigations into deviations, non-conformances, and quality incidents, implementing corrective and preventive actions as necessary.
Stay abreast of changes in pharmaceutical regulations and guidelines, ensuring timely implementation of required changes.
Serve as the primary point of contact for regulatory agencies during inspections and audits, facilitating responses and corrective actions as needed.
Review and approve regulatory submissions, including drug applications, variations, and registrations.
Collaborate with supply chain and procurement teams to ensure timely availability of raw materials, components, and packaging materials.
Optimize inventory management processes to minimize stockouts and excess inventory while maintaining continuity of supply.
Develop and manage budgets for the pharmaceutical site, monitoring expenses and optimizing resource utilization to achieve financial targets.
Identify opportunities for cost savings and process improvements to enhance profitability.
Prioritize the health and safety of employees by implementing and enforcing robust safety protocols and procedures.
Ensure compliance with environmental regulations and sustainability initiatives, minimizing the site's environmental impact.
Qualifications:
Bachelor's or Master's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering, or related field.
7-10 years experience in pharmaceutical manufacturing, with progressive leadership responsibilities.
Strong leadership and managerial skills, with the ability to inspire and motivate teams.
Excellent communication, interpersonal, and problem-solving abilities.
Proven track record of driving operational excellence, quality improvement, and regulatory compliance.
Familiarity with continuous improvement methodologies such as Lean, Six Sigma, or Total Quality Management.
Proficiency in computer systems and software applications relevant to pharmaceutical manufacturing and quality management.
Certification in Quality Management (e.g., Certified Quality Manager, Six Sigma Black Belt) is desirable.