Are you a detail-oriented individual with a passion for ensuring products are of the highest quality Do you have experience in quality assurance within the pharmaceutical or biotechnology industry If so, we have an exciting opportunity for you. IPL Biologicals is currently seeking a Quality Assurance Manager to join our team.
At IPL Biologicals, we are dedicated to developing and producing high-quality biological products for the healthcare industry. As the Quality Assurance Manager, you will play a critical role in ensuring that our products meet regulatory requirements and adhere to the highest quality standards.
Key Responsibilities
- Develop and implement quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.
- Oversee the implementation and maintenance of the Quality Management System (QMS) to ensure product quality and consistency.
- Lead and manage a team of quality assurance professionals, providing guidance and support to ensure the team's success.
- Conduct regular audits and inspections of manufacturing processes, facilities, and documentation to identify and address quality issues.
- Collaborate with cross-functional teams, including production, research and development, and regulatory affairs, to ensure quality objectives are met throughout the product lifecycle.
- Investigate and resolve product quality issues, non-conformances, and customer complaints in a timely and effective manner.
- Develop and maintain key performance indicators (KPIs) to monitor and improve the quality of products and processes.
- Prepare and present reports on quality metrics and performance to senior management and regulatory authorities.
Qualifications
- Bachelor's degree in a scientific discipline, such as biology, chemistry, or related field. Advanced degree preferred.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical or biotechnology industry, with at least 2 years in a managerial or leadership role.
- Strong understanding of regulatory requirements, including FDA and other global regulatory agencies, as they relate to biologics manufacturing.
- Excellent communication and interpersonal skills, with the ability to effectively lead and motivate a team.
- Analytical mindset with the ability to identify and solve complex quality issues.
- Experience with quality management systems, such as ISO 9001, and continuous improvement methodologies, such as Six Sigma or Lean, is a plus.
If you are ready to take on this exciting opportunity and contribute to the success of IPL Biologicals, we encourage you to apply for the position of Quality Assurance Manager. Join our team and help us continue to deliver high-quality biological products to improve the lives of patients around the world. We look forward to welcoming you to our team.
