Oversee quality assurance activities throughout the product lifecycle, from development to manufacturing and distribution.
Develop and maintain quality assurance policies and procedures in line with industry regulations and standards. Prepare and review documentation for regulatory submissions and audits.
Design and execute validation and verification protocols for manufacturing processes, equipment, and systems. Ensure that validation activities meet regulatory requirements and are documented appropriately.
Lead and participate in internal and external audits, including FDA and other regulatory agency inspections. Address audit findings and implement corrective and preventive actions (CAPAs) to resolve any issues.
Identify opportunities for process improvements within the quality assurance framework. Implement best practices to enhance product quality and efficiency while maintaining compliance with regulatory standards.
Provide leadership and mentorship to junior QA staff, offering guidance on best practices, regulatory compliance, and QA processes. Foster a culture of quality and continuous improvement within the QA team.
Develop and review standard operating procedures (SOPs), quality manuals, and other documentation related to quality assurance. Prepare and present quality reports to senior management and other stakeholders.
Collaborate with R&D, manufacturing, and other departments to ensure that quality considerations are integrated into product development and manufacturing processes. Communicate effectively with cross-functional teams to address quality issues and ensure alignment with business objectives.
Qualifications:
Bachelor’s degree in Chemistry, Biology, or a related field. Advanced degrees or certifications in Quality Assurance, Regulatory Affairs, or Pharmaceutical Sciences are a plus.
Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
In-depth knowledge of FDA, EMA, and other international regulatory requirements related to pharmaceutical manufacturing and quality assurance.
Proficiency in quality management systems (QMS), validation techniques, and GMP compliance. Experience with electronic lab notebooks (ELNs) and quality management software is a plus.
Strong analytical and problem-solving skills, with the ability to assess complex quality issues and implement effective solutions.
Excellent verbal and written communication skills. Ability to clearly articulate technical information to both technical and non-technical stakeholders.
Exceptional attention to detail and a commitment to maintaining high standards of quality and compliance.
Proven leadership abilities with experience in mentoring and developing QA teams.
