Director, Quality Assurance
Default Brand, Fremont, CA, United States
Welcome to Nova Pneuma — a company built on innovation and a shared commitment to creating meaningful medicines for patients in need. Innovation requires bold thinking and the courage to persevere despite setbacks, criticism, and uncertainty. We believe in providing our employees with a purpose centered on innovation, along with the freedom to take thoughtful risks in pursuit of creative ambition. By fostering a culture of curiosity, collaboration, and resilience, we create the foundation for both scientific breakthroughs and long-term value for our company.
Job Summary
The Director of Quality Assurance is a leader responsible for shaping, executing, and continuously improving the organization’s Quality Assurance strategy. Reporting directly to the Head of Quality, this role ensures that products, processes, and systems meet the highest standards of compliance, reliability, and customer satisfaction. The Director will lead cross‑functional quality initiatives, strengthen the quality culture, and drive operational excellence across the business. This role contributes to and supports Nova Pneuma’s quality systems to ensure compliance for clinical and commercial distributions. Responsibilities
Quality Strategy & Leadership Develop and implement the company’s Quality Assurance strategy in alignment with the Head of Quality and organizational goals. Lead, mentor, and develop a high‑performing QA team, fostering accountability, collaboration, and continuous improvement. Serve as a key advisor to senior leadership on quality risks, trends, and opportunities. Quality Systems & Compliance Oversee the design, implementation, and maintenance of Quality Management Systems (QMS) aligned with relevant standards (e.g., ISO 9001, ISO 13485, GMP, GxP, or industry‑specific requirements). Ensure compliance with regulatory bodies and customer requirements through robust documentation, audits, and process controls. May lead internal and external audits, ensuring timely resolution of findings and sustainable corrective actions. Operational Excellence Drive continuous improvement initiatives using methodologies such as Lean, Six Sigma, or root‑cause analysis. Establish and monitor key quality metrics, ensuring data‑driven decision‑making and transparency across the organization. Partner with functional areas such as Manufacturing Operations, PR&D, Device Development, QC, Supply Chain etc to proactively identify quality risks and implement preventive measures. Product & Process Quality Oversee product quality throughout the lifecycle—from design and development through manufacturing, release, and post‑market performance. Ensure robust validation, verification, testing, and inspection processes. Provide QA support for cross‑functional investigations of nonconformances, customer complaints, and field issues, ensuring timely and effective CAPA execution. Act as a primary quality representative for customers, suppliers, and regulatory agencies. Strengthen customer satisfaction by ensuring consistent delivery of high‑quality products and services. Communicate quality performance, risks, and initiatives to executive leadership and key stakeholders. Provide QA oversight of risk management activities ensuring integrated risk files for combination products. Partner with PR&D and Device Development to ensure design controls, human factors engineering, and usability studies meet regulatory expectations. Ensure robust verification, validation, and design transfer processes for both device and drug‑device interfaces Education and Experience Required
Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred. 10+ years of progressive experience in Quality Assurance, with at least 5 years in a leadership role. Deep knowledge of quality standards, regulatory requirements, and industry best practices. Demonstrated success leading teams and driving cross‑functional quality initiatives. Strong analytical, problem‑solving, and communication skills. Certifications such as ASQ CQE, CQA, or Six Sigma Black Belt are a plus. Familiarity with electronic Quality Management Systems, (DOT compliance, Veeva, Trackwise etc) Physical Requirements
Prolonged periods of sitting at a desk and working on a computer Potentially prolonged periods standing Must be able to lift up to 15 pounds at times Must be willing to travel Compensation
The base salary for this role starts at $230,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions. Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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The Director of Quality Assurance is a leader responsible for shaping, executing, and continuously improving the organization’s Quality Assurance strategy. Reporting directly to the Head of Quality, this role ensures that products, processes, and systems meet the highest standards of compliance, reliability, and customer satisfaction. The Director will lead cross‑functional quality initiatives, strengthen the quality culture, and drive operational excellence across the business. This role contributes to and supports Nova Pneuma’s quality systems to ensure compliance for clinical and commercial distributions. Responsibilities
Quality Strategy & Leadership Develop and implement the company’s Quality Assurance strategy in alignment with the Head of Quality and organizational goals. Lead, mentor, and develop a high‑performing QA team, fostering accountability, collaboration, and continuous improvement. Serve as a key advisor to senior leadership on quality risks, trends, and opportunities. Quality Systems & Compliance Oversee the design, implementation, and maintenance of Quality Management Systems (QMS) aligned with relevant standards (e.g., ISO 9001, ISO 13485, GMP, GxP, or industry‑specific requirements). Ensure compliance with regulatory bodies and customer requirements through robust documentation, audits, and process controls. May lead internal and external audits, ensuring timely resolution of findings and sustainable corrective actions. Operational Excellence Drive continuous improvement initiatives using methodologies such as Lean, Six Sigma, or root‑cause analysis. Establish and monitor key quality metrics, ensuring data‑driven decision‑making and transparency across the organization. Partner with functional areas such as Manufacturing Operations, PR&D, Device Development, QC, Supply Chain etc to proactively identify quality risks and implement preventive measures. Product & Process Quality Oversee product quality throughout the lifecycle—from design and development through manufacturing, release, and post‑market performance. Ensure robust validation, verification, testing, and inspection processes. Provide QA support for cross‑functional investigations of nonconformances, customer complaints, and field issues, ensuring timely and effective CAPA execution. Act as a primary quality representative for customers, suppliers, and regulatory agencies. Strengthen customer satisfaction by ensuring consistent delivery of high‑quality products and services. Communicate quality performance, risks, and initiatives to executive leadership and key stakeholders. Provide QA oversight of risk management activities ensuring integrated risk files for combination products. Partner with PR&D and Device Development to ensure design controls, human factors engineering, and usability studies meet regulatory expectations. Ensure robust verification, validation, and design transfer processes for both device and drug‑device interfaces Education and Experience Required
Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred. 10+ years of progressive experience in Quality Assurance, with at least 5 years in a leadership role. Deep knowledge of quality standards, regulatory requirements, and industry best practices. Demonstrated success leading teams and driving cross‑functional quality initiatives. Strong analytical, problem‑solving, and communication skills. Certifications such as ASQ CQE, CQA, or Six Sigma Black Belt are a plus. Familiarity with electronic Quality Management Systems, (DOT compliance, Veeva, Trackwise etc) Physical Requirements
Prolonged periods of sitting at a desk and working on a computer Potentially prolonged periods standing Must be able to lift up to 15 pounds at times Must be willing to travel Compensation
The base salary for this role starts at $230,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions. Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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