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Quality Assurance Director Jobs

18 Job Offers

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Sr. Director, Quality Assurance Engineering
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Lead QA strategy across three sites for Western Digital in Bayan Lepas. Requires 20+ years in quality engineering, 10 in leadership, ISO 9001 expertise, and multi-site team management. Drive KPIs, governance, and digital quality solutions.
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Director, Quality Assurance Engineering
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Lead Quality Assurance Engineering at WD in Kuching. Requires 10+ years in QA or operations, including 5 in leadership, plus HDD manufacturing expertise. Drive quality strategy and team development in a fast-paced environment.
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Director - Clinical Research Quality Assurance - FT - Days - MHS
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Lead clinical research quality assurance at a Hollywood institution. Oversee GCP compliance, audits, and CAPA processes. Requires 8+ years of research experience, including 4 in leadership, and deep FDA/OHRP knowledge.
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Senior Manager / Associate Director, Clinical Quality Assurance
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Lead GCP quality oversight at Beam Therapeutics in Cambridge. Manage CRO and vendor qualification, audits, and risk-based frameworks. Requires 8+ years in clinical/GCP quality and strong FDA/EMA/ICH knowledge.
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Associate Director / Director, Quality Assurance
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Lead QA strategy for a growing biotech in San Diego. Own inspection readiness, document control, GMP training, and supplier audits for an outsourced manufacturing model. Requires 10+ years of QA experience.
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Director/Sr. Director, Quality Assurance Operations
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Lead Quality Assurance Operations at Genezen in Lexington, driving cGMP compliance and QMS excellence for gene therapy manufacturing. Oversee investigations, CAPA, and material disposition. Enjoy competitive benefits including 401(k) match and healthcare.
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Director, Quality Assurance
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IT Director - IT Service Management and Quality Assurance
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Senior Director / Director, Quality Assurance
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Sr. Director, Sterility Assurance – Global Quality Technical Operations
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Director, R&D Quality Assurance Pharmacovigilance
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Director, Quality Assurance
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139400.00 - 205000.00 USD / Year
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Technical Director - Quality Assurance / Quality Control and Specifications
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Senior Director, Quality Assurance
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Senior Director, Quality Assurance role at Theradaptive in Frederick, MD. Lead an integrated QMS for cutting-edge regenerative medicine combination products. Requires 15+ years in biotech/medtech quality, FDA inspection expertise, and experience with protein biologics. Drive digital QMS transform...
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Senior Director, Product Quality Assurance
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Senior Director, Product Quality Assurance sought in Cambridge, US, to lead GMP compliance across CDMOs and external partners. This critical role drives quality strategy for Beam’s evolution from research to commercial launch. Requires 15+ years in pharma/biotech with CT/GT/biologics expertise, 7...
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260000.00 - 320000.00 USD / Year
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Associate Director / Director, Clinical Quality Assurance
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Associate Director/Director of Clinical Quality Assurance needed in Cambridge, MA. Lead GCP inspection readiness, risk assessments, and health authority inspections (FDA, EMA). Requires 10+ years of GCP quality experience, deep expertise in GCP R3, and a scientific degree. Drive quality oversight...
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185000.00 - 260000.00 USD / Year
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Associate Director, Product Quality Assurance
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Associate Director, Product Quality Assurance sought for Cell and Gene Therapy programs in Cambridge, MA. This strategic Quality leader partners with CMC teams across the full product lifecycle, from development to commercialization. Requires 12+ years pharma/biotech experience, including 4+ year...
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185000.00 - 225000.00 USD / Year
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Director, Quality Assurance
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Batesville seeks a Director, Quality Assurance to lead multi-site manufacturing and logistics quality operations near Batesville, IN or Manchester, TN. This role requires 10+ years of progressive QA experience, 3-5 years in leadership, and expertise in ISO 9000 standards. You will drive strategic...
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145000.00 - 180000.00 USD / Year
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About the Quality Assurance Director role

A Quality Assurance (QA) Director is a senior-level executive responsible for the overarching strategy, leadership, and execution of an organization's quality management systems. This pivotal role transcends simple defect detection, focusing instead on building a culture of excellence, preventing issues before they occur, and ensuring that products, services, and processes consistently meet or exceed customer and regulatory standards. For professionals seeking to shape quality at a strategic level, Quality Assurance Director jobs represent the apex of a career in quality control and assurance.

Professionals in this role are strategic leaders who define the vision and roadmap for the entire quality function. They are responsible for establishing the quality standards, policies, and procedures that guide the organization. A core part of their mandate is to design and implement robust, forward-thinking quality frameworks and methodologies that are scalable and effective across various departments, from software development and manufacturing to customer service and operational risk management. They champion the voice of the customer, ensuring that quality metrics are aligned with delivering exceptional user experiences and outcomes.

Typical responsibilities for a QA Director are comprehensive and leadership-focused. They include leading, mentoring, and growing a high-impact team of quality managers and engineers. They manage the quality assurance budget, resource allocation, and headcount planning. A significant portion of their role involves cross-functional partnership; they collaborate closely with executive leadership, engineering, product management, operations, risk, and compliance to embed quality into every stage of the development and service lifecycle. They are also accountable for driving continuous improvement initiatives, conducting deep-dive root cause analysis on major issues, and presenting key trends, risks, and strategic insights to senior management and stakeholders. Furthermore, they often oversee the adoption of new technologies, such as advanced automation and artificial intelligence, to enhance testing efficiency and predictive quality analytics.

The skills and requirements for these leadership positions are demanding. Most roles require a bachelor's degree in a relevant field, with many preferring a master's degree, coupled with 10-15 years of progressive experience in quality assurance or a related control function, including substantial people management experience. Essential skills include exceptional leadership and team-building capabilities, strategic thinking, and sophisticated business acumen. They must possess strong analytical and problem-solving skills to evaluate complex processes and data. Advanced communication and relationship management skills are non-negotiable, as the role requires influencing executive audiences and fostering strong partnerships across the business. A deep understanding of risk management, regulatory compliance, and industry best practices is also typically required.

In essence, a Quality Assurance Director is the chief architect of an organization's quality culture, turning quality assurance from a final checkpoint into a strategic advantage. For those with the vision and expertise, pursuing Quality Assurance Director jobs offers a challenging and rewarding opportunity to lead enterprise-wide quality initiatives and make a lasting impact on an organization's products, reputation, and customer trust.