Senior Supplier Quality Engineer ensuring quality for NVIDIA's AI systems through supplier assessments and audits. Collaborating with teams for continuous quality improvements and mentoring suppliers.
About the role
- Senior Quality Assurance Specialist at Emergent BioSolutions overseeing quality systems for combination products. Responsible for compliance, Quality Management, and regulatory interactions.
Responsibilities
- Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise/specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).
- The role is responsible for (1) QA lead for internal and external projects (2) independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements (3) executing Quality Management System requirements in support of commercial and developmental programs (4) ensuring the realization of industry best practices for GxP and (5) serving as quality approval proxy as required.
- This position is responsible for performing various functions as an owner, reviewer and/or approver.
- These functions include deviations, change controls, CAPAs, Complaints, Quality Risk Management validation and transfer protocols reports, trend evaluation and reporting, technical review design of history files (and its supporting documentation), review of critical procedures and processes, lead process changes and new product introduction, assist with regulatory responses, and develop and implement process improvements.
Requirements
- Bachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.
- Minimum 8 years of cGMP experience including Manufacturing and Quality Assurance experience
- 2-3 years in a senior or leadership Quality Assurance role
- Qualified Person experience preferable
- Broad experience and thorough understanding of international GMP Quality Management System regulations for drugs and devices including ICH Guidelines, ISO 13485, FDA 21 CFR Parts 210, 211 and 820, European (EudraLex Volume 4) and Health Canada GMPs
- Demonstrated experience owning, driving and leading Quality initiatives
- Demonstrated experience working independently with internal and external partners
- Experience as process owner for deviation, CAPA, change management, and self-inspection programs as well as managing 3rd party audits and inspections is preferable.
- Experience with quality risk management will be considered an asset.
- Must be a self-starter with ability to work independently
- Ability to manage and deliver multiple priorities, projects and tasks in a dynamic environment using own initiative with little instruction on routine work, general instructions on new assignments
- Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.
- Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
- Ability to lead Change Management activities and strong Project Management knowledge
- Excellent communication skills, both written and verbal
- Ability to exercise judgment to determine appropriate corrective actions
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
- Ability to use computer programs.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
- Paid time off
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Quality Analyst engaging in product development and ensuring quality through effective testing practices at Webmotors. Collaborates with product and development teams to enhance software quality and user experience.
QA Lead overseeing SAP S/4HANA functional testing for client - driven projects at Trissential. Leading testing initiatives and mentoring QA teams in collaborative environments.
Quality Assurance Analyst ensuring product release quality and compliance in radio pharmaceuticals while contributing to medical innovations.
Quality Engineer at Linamar responsible for quality planning and compliance in manufacturing processes. Addressing customer complaints and evaluating defective parts.
Quality Assurance Leader ensuring site - level quality compliance at Newell Brands. Leading audits and managing quality systems in alignment with GMP and ISO standards.
Senior Quality Engineer specializing in building automated testing frameworks at Fanatics Commerce. Collaborating with Software Engineers to streamline integration processes for enhancing customer satisfaction.
Quality Engineering Intern involved in AI tools and technologies. Hands - on experience with projects and skill development at WM.
Senior Penetration Tester conducting security assessments for various sectors, leading project teams and collaborating in information security.
Senior Penetration Tester conducting penetration tests on various security domains. Collaborating with teams to enhance security strategies and ensure system resilience.