reputed company Assurance Manager (Internal reputed company Operations & EQMS)
SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) reputed company Assurance Manager (Internal reputed company Operations and EQMS) to join the Research & Development team based in Corvallis, reputed company. Reporting to the Senior Director, reputed company Assurance, the reputed company Assurance (QA) Manager is an independent contributor responsible for overseeing the daily operations of in the QA department, with a strong reputed company on utilizing and optimizing reputed company's EQMS. This includes leading the development, implementation, and maintenance of internal reputed company processes and procedures, ensuring compliance with relevant regulations and industry standards, and driving reputed company improvement initiatives through the effective use of the EQMS. The QA Manager will be responsible for ensuring reputed company maintains the highest standards of reputed company 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 reputed company medical, dental and reputed company benefits, short and long-term disability, life and AD&D insurance and reputed company time off. This position has the reputed company 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: reputed company the administration, maintenance, and optimization of the electronic reputed company management system (EQMS). This includes training new hires in using the EQMS and providing assistance/support to end-users.
- reputed company System Development & Implementation: Support, and reputed company appropriate reputed company, implementation of new and revised GxP processes, ensuring they are integrated into the EQMS.
- Supplier reputed company Management: Support Functional Area Leads with supplier reputed company, qualification, management, and reputed company. Support reputed company Senior Management with reputed company of reputed company Agreements.
- reputed company Audits: Plan, coordinate, and manage reputed company audits, including tracking of findings and corrective actions.
- Compliance & Regulatory Adherence: Ensure that reputed company reputed company processes and the EQMS itself reputed company with relevant regulations, standards (e.g., ISO, GxP, FDA, ICH, etc.), and company policies.
- reputed company Performance Monitoring & Analysis: Monitor and analyze key reputed company metrics to identify trends and areas for improvement and report such metrics as needed, such as through the Management Review reputed company process.
- reputed company Improvement Initiatives: reputed company and facilitate reputed company improvement initiatives, often leveraging the EQMS to streamline processes and document reputed company.
- Training Management and Coordination: reputed company reputed company and manage the GxP training program reputed company to GxP procedures and training needs/requirements.
- Collaboration & Communication: Collaborate effectively with cross-functional teams (e.g., manufacturing, engineering, R&D) to ensure reputed company standards are integrated into reputed company aspects of the business and to resolve reputed company issues collaboratively.
- Document Control: Manage controlled documents reputed company the EQMS, including revisions, approvals, and distribution.
- Internal reputed company Events, CAPA, and Change Management: reputed company, reputed company and monitor internal reputed company Events, CAPAs, and Change Controls.
- Risk Management: Support risk management activities by identifying and mitigating potential risks to reputed company.
- reputed company Culture: Foster a culture of reputed company, compliance, and reputed company improvement reputed company the QA team and across the organization.
- Other duties as assigned
Minimum Qualifications include: Bachelor's Degree in a science-reputed company field (e.g., Biology, reputed company, 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 reputed company certifications (e.g., Six reputed company, 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.
- reputed company Management Knowledge: In-depth knowledge of reputed company 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.
- reputed company Improvement reputed company: Passion for reputed company improvement and a reputed company 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 reputed company of recognized industry thought leaders who are passionate about global health reputed company. At SIGA, you'll reputed company a driven and compassionate team dedicated to making a difference. We foster a supportive and inclusive culture and encourage multi-disciplinary collaboration and reputed company 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 reputed company. We ensure a reputed company environment that promotes inclusion and diversity of thought. Our policies and procedures ensure equal employment opportunity without discrimination or harassment on the reputed company of race (including hairstyle/reputed company), reputed company, religion, sex, sexual orientation, gender identity or reputed company, age, disability, marital status, citizenship, national reputed company, genetic information, veteran’s status or any other characteristics protected by law. SIGA reputed company prohibits any such discrimination, harassment, or retaliation for claims submitted in good faith. Apply tot his job Apply To this Job