Quality Assurance Manager (Internal Quality Operations & EQMS)
Posted 2025-08-15
Remote, USA
Full Time
Immediate Start
SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) Quality Assurance Manager (Internal Quality Operations and EQMS) to join the Research & Development team based in Corvallis, Oregon. Reporting to the Senior Director, Quality Assurance, the Quality Assurance (QA) Manager is an independent contributor responsible for overseeing the daily operations of in the QA department, with a strong focus on utilizing and optimizing the company's EQMS. This includes leading the development, implementation, and maintenance of internal quality processes and procedures, ensuring compliance with relevant regulations and industry standards, and driving continuous improvement initiatives through the effective use of the EQMS. The QA Manager will be responsible for ensuring the company maintains the highest standards of quality in its products and its internal processes.
As a full-time employee, the QA Manager is eligible for SIGA's full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option of a hybrid office or remote work arrangement and may require domestic and international travel up to 10% of the time.
Responsibilities for this position include:
• EQMS Management: Oversee the administration, maintenance, and optimization of the electronic quality management system (EQMS). This includes training new hires in using the EQMS and providing assistance/support to end-users.
• Quality System Development & Implementation: Support, and when appropriate lead, implementation of new and revised GxP processes, ensuring they are integrated into the EQMS.
• Supplier Quality Management: Support Functional Area Leads with supplier section, qualification, management, and oversight. Support Quality Senior Management with oversight of Quality Agreements.
• Quality Audits: Plan, coordinate, and manage quality audits, including tracking of findings and corrective actions.
• Compliance & Regulatory Adherence: Ensure that all quality processes and the EQMS itself comply with relevant regulations, standards (e.g., ISO, GxP, FDA, ICH, etc.), and company policies.
• Quality Performance Monitoring & Analysis: Monitor and analyze key quality metrics to identify trends and areas for improvement and report such metrics as needed, such as through the Management Review Board process.
• Quality Improvement Initiatives: Lead and facilitate quality improvement initiatives, often leveraging the EQMS to streamline processes and document progress.
• Training Management and Coordination: Provide oversight and manage the GxP training program related to GxP procedures and training needs/requirements.
• Collaboration & Communication: Collaborate effectively with cross-functional teams (e.g., manufacturing, engineering, R&D) to ensure quality standards are integrated into all aspects of the business and to resolve quality issues collaboratively.
• Document Control: Manage controlled documents within the EQMS, including revisions, approvals, and distribution.
• Internal Quality Events, CAPA, and Change Management: Oversee, track and monitor internal Quality Events, CAPAs, and Change Controls.
• Risk Management: Support risk management activities by identifying and mitigating potential risks to quality.
• Quality Culture: Foster a culture of quality, compliance, and continuous improvement within the QA team and across the organization.
• Other duties as assigned
Minimum Qualifications include:
Bachelor's Degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) with 10+ years of relevant GMP experience in a regulated industry, such as pharmaceuticals, biotechnology, or device.
Proven experience in QA, with significant experience managing and administrating EQMS.
Relevant professional certifications (e.g., Six Sigma, ASQ certifications preferred.
The successful candidate will possess the following knowledge and abilities:
• EQMS Proficiency: Strong technical expertise in EQMS systems, including validation, administration, configuration, and maintenance.
• Quality Management Knowledge: In-depth knowledge of quality management systems, methodologies, and tools.
• Regulatory Compliance: Solid understanding of relevant industry regulations (e.g., FDA, ISO, ICH, etc.) and experience implementing compliance.
• Analytical & Problem-Solving Skills: Strong analytical and problem-solving abilities, including data analysis for identifying trends and implementing improvements.
• Communication & Collaboration: Excellent communication skills, both written and verbal, for effective collaboration with internal teams and external stakeholders.
• Attention to Detail: Meticulous attention to detail in reviewing processes, documentation, and data.
• Continuous Improvement Focus: Passion for continuous improvement and a track record of driving process enhancements.
About SIGA:
SIGA is a leader in global health, developing medicines to prevent and treat emerging infectious diseases with high unmet medical needs.
Join our team of recognized industry thought leaders who are passionate about global health security. At SIGA, you'll find a driven and compassionate team dedicated to making a difference. We foster a supportive and inclusive culture and encourage multi-disciplinary collaboration and professional development. Discover a fulfilling career with opportunities for advancement while protecting lives around the world.
We foster a workplace where every individual is respected and appreciated for the unique value they bring to our team. We ensure a professional environment that promotes inclusion and diversity of thought. Our policies and procedures ensure equal employment opportunity without discrimination or harassment on the basis of race (including hairstyle/texture), color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, veteran's status or any other characteristics protected by law. SIGA strictly prohibits any such discrimination, harassment, or retaliation for claims submitted in good faith. Apply tot his job
As a full-time employee, the QA Manager is eligible for SIGA's full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off. This position has the option of a hybrid office or remote work arrangement and may require domestic and international travel up to 10% of the time.
Responsibilities for this position include:
• EQMS Management: Oversee the administration, maintenance, and optimization of the electronic quality management system (EQMS). This includes training new hires in using the EQMS and providing assistance/support to end-users.
• Quality System Development & Implementation: Support, and when appropriate lead, implementation of new and revised GxP processes, ensuring they are integrated into the EQMS.
• Supplier Quality Management: Support Functional Area Leads with supplier section, qualification, management, and oversight. Support Quality Senior Management with oversight of Quality Agreements.
• Quality Audits: Plan, coordinate, and manage quality audits, including tracking of findings and corrective actions.
• Compliance & Regulatory Adherence: Ensure that all quality processes and the EQMS itself comply with relevant regulations, standards (e.g., ISO, GxP, FDA, ICH, etc.), and company policies.
• Quality Performance Monitoring & Analysis: Monitor and analyze key quality metrics to identify trends and areas for improvement and report such metrics as needed, such as through the Management Review Board process.
• Quality Improvement Initiatives: Lead and facilitate quality improvement initiatives, often leveraging the EQMS to streamline processes and document progress.
• Training Management and Coordination: Provide oversight and manage the GxP training program related to GxP procedures and training needs/requirements.
• Collaboration & Communication: Collaborate effectively with cross-functional teams (e.g., manufacturing, engineering, R&D) to ensure quality standards are integrated into all aspects of the business and to resolve quality issues collaboratively.
• Document Control: Manage controlled documents within the EQMS, including revisions, approvals, and distribution.
• Internal Quality Events, CAPA, and Change Management: Oversee, track and monitor internal Quality Events, CAPAs, and Change Controls.
• Risk Management: Support risk management activities by identifying and mitigating potential risks to quality.
• Quality Culture: Foster a culture of quality, compliance, and continuous improvement within the QA team and across the organization.
• Other duties as assigned
Minimum Qualifications include:
Bachelor's Degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) with 10+ years of relevant GMP experience in a regulated industry, such as pharmaceuticals, biotechnology, or device.
Proven experience in QA, with significant experience managing and administrating EQMS.
Relevant professional certifications (e.g., Six Sigma, ASQ certifications preferred.
The successful candidate will possess the following knowledge and abilities:
• EQMS Proficiency: Strong technical expertise in EQMS systems, including validation, administration, configuration, and maintenance.
• Quality Management Knowledge: In-depth knowledge of quality management systems, methodologies, and tools.
• Regulatory Compliance: Solid understanding of relevant industry regulations (e.g., FDA, ISO, ICH, etc.) and experience implementing compliance.
• Analytical & Problem-Solving Skills: Strong analytical and problem-solving abilities, including data analysis for identifying trends and implementing improvements.
• Communication & Collaboration: Excellent communication skills, both written and verbal, for effective collaboration with internal teams and external stakeholders.
• Attention to Detail: Meticulous attention to detail in reviewing processes, documentation, and data.
• Continuous Improvement Focus: Passion for continuous improvement and a track record of driving process enhancements.
About SIGA:
SIGA is a leader in global health, developing medicines to prevent and treat emerging infectious diseases with high unmet medical needs.
Join our team of recognized industry thought leaders who are passionate about global health security. At SIGA, you'll find a driven and compassionate team dedicated to making a difference. We foster a supportive and inclusive culture and encourage multi-disciplinary collaboration and professional development. Discover a fulfilling career with opportunities for advancement while protecting lives around the world.
We foster a workplace where every individual is respected and appreciated for the unique value they bring to our team. We ensure a professional environment that promotes inclusion and diversity of thought. Our policies and procedures ensure equal employment opportunity without discrimination or harassment on the basis of race (including hairstyle/texture), color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, veteran's status or any other characteristics protected by law. SIGA strictly prohibits any such discrimination, harassment, or retaliation for claims submitted in good faith. Apply tot his job