Quality Manager

About the role

As a Quality Manager at Bamboohr, you will play a pivotal role in ensuring that our pharmaceutical products meet the highest standards of quality and compliance. You will lead a dedicated team focused on maintaining and enhancing quality systems, processes, and documentation. Your expertise will be crucial in driving continuous improvement initiatives and ensuring adherence to regulatory requirements. This position offers an exciting opportunity to contribute to the health and well-being of patients while working in a dynamic and collaborative environment.

Key facts

What you'll do

• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory standards and internal policies.
• Conduct regular audits of manufacturing processes, facilities, and documentation to identify areas for improvement and ensure adherence to quality standards.
• Collaborate with cross-functional teams, including production, regulatory affairs, and research and development, to ensure quality is integrated into all aspects of operations.
• Lead investigations into product quality issues, including root cause analysis and corrective action implementation, to prevent recurrence.
• Prepare and present quality metrics and reports to senior management, highlighting trends, issues, and opportunities for improvement.
• Develop and deliver training programs for staff on quality standards, procedures, and best practices to foster a culture of quality throughout the organization.
• Manage supplier quality assessments and ensure that all raw materials and components meet established quality criteria before use in production.
• Stay current with industry regulations and standards, including FDA, ISO, and cGMP, to ensure compliance and best practices are followed.
• Act as the primary point of contact for regulatory inspections and audits, providing necessary documentation and responses to inquiries.
• Drive continuous improvement initiatives using quality tools such as Six Sigma, Lean, and CAPA to enhance product quality and operational efficiency.
• Foster a proactive quality mindset within the organization by promoting open communication and collaboration among all departments.
• Participate in the development of new products by providing quality input during the design and development phases to ensure quality is built into the product from the outset.

Requirements

• Bachelor's degree in a relevant field such as Life Sciences, Engineering, or Quality Management; advanced degree preferred.
• A minimum of 5 years of experience in quality management within the pharmaceutical or biotechnology industry.
• Strong knowledge of regulatory requirements, including FDA regulations, ISO standards, and cGMP practices.
• Proven experience in leading quality audits and investigations, with a track record of implementing effective corrective actions.
• Excellent analytical skills and the ability to interpret complex data to drive decision-making.
• Strong leadership and team management skills, with the ability to motivate and develop a high-performing quality team.
• Exceptional communication skills, both written and verbal, with the ability to present complex information clearly to diverse audiences.
• Proficiency in quality management software and tools, as well as Microsoft Office Suite.

Nice to have

• Certification in Quality Management (e.g., ASQ Certified Quality Manager or equivalent) is a plus.
• Experience with Lean Six Sigma methodologies and tools.
• Familiarity with electronic quality management systems (eQMS) and document control software.
• Previous experience in a startup or fast-paced environment is advantageous.
• Multilingual abilities can be beneficial in a diverse workplace.

Skills & tools

• Quality Management Systems (QMS)
• Statistical Process Control (SPC)
• Root Cause Analysis (RCA)
• Corrective and Preventive Actions (CAPA)
• Lean and Six Sigma methodologies
• Regulatory compliance knowledge (FDA, ISO, cGMP)
• Auditing skills
• Data analysis and reporting tools

Practical notes

• This position is based in Laguna Hills, California, and may require occasional travel for audits and inspections.
• The role may involve working extended hours during critical project phases or regulatory inspections.
• Candidates must be eligible to work in the United States and may require visa sponsorship.

If you are passionate about quality assurance and are looking to make a significant impact in the pharmaceutical industry, we invite you to apply for the Quality Manager position at Bamboohr. Join us in our mission to enhance patient health through high-quality pharmaceutical products.