Staff Quality Process Engineer for GRAIL working on quality engineering projects and compliance. Leading initiatives for early cancer detection technologies in North Carolina.
About the role
- Managing quality assurance for external suppliers in the pharmaceutical industry. Ensuring compliance with cGMP and regulatory requirements for biologics production.
Responsibilities
- Responsible for managing quality aspects at external suppliers to ensure compliance with cGMP and regulatory requirements
- Provides direction and formulates strategies to maintain and improve external supplier quality oversight
- Establishes and maintains quality relationship with suppliers
- Acts as Single Point of Contact / SPOC for all quality related activities
- Provides quality presence and input to technical meetings with external suppliers
- Conducts necessary trainings for assigned duties
- Ensures valid Quality Agreement and external supplier quality risk assessments are in place
- Ensures site readiness for regulatory inspections and quality audits
- Assesses quality trends and drives continuous improvement
- Manages all quality issues (complaints, deviations)
- Ensures investigations and required actions are taken timely
- Ensures activities related to change requests are managed appropriately
- Ensures QA Oversight during product transfers
- Implements and monitors Key Performance Indicators (KPI)
Requirements
- Bachelor or higher in Biochemistry, Chemistry, Microbiology or a related science
- Fluent English mandatory
- Min 8 years of experience in the pharmaceutical industry.
- Min 5 years of experience in manufacturing of sterile pharmaceuticals.
- Expert knowledge in biosimilar pharmaceutical processes and manufacturing of biologics.
- Min 5 years of experience in operational quality assurance.
- Expert knowledge of cGMP requirements for major regulated markets (EU, US).
- Advanced experience with FDA, EMEA and other Health Authorities.
- Expert in risk management.
- Advanced understanding of project management.
- Expert in communication and advanced negotiation skills.
- Advanced decision-making skills.
- Basic leadership skills.
Benefits
- Commitment to Diversity & Inclusion
- Professional development opportunities
- Inclusive work environment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Quality Assurance Specialist managing and executing quality assurance for Duck Creek implementations and releases. Overseeing test planning, execution, defect management, ensuring high - quality deliveries.
Controls Testing & QA Specialist at Binance overseeing AML/CTF compliance and reporting. Designing controls testing plans and ensuring regulatory adherence in a hybrid work environment.
Tech Lead QA leading the QA team in São Paulo, responsible for defining testing strategy and ensuring best practices. Collaborating closely with development and product teams to enhance test quality.
Functional QA Specialist responsible for testing Salesforce solutions at GFT. Engaging in various QA duties including test planning, execution, and collaboration with development teams.
Quality Engineer ensuring products and processes meet defined standards at ZF. Collaborating with teams to improve quality and compliance.
Process Quality Engineer improving quality management at ZF Automotive Systems. Drive process quality improvements and train workers in quality awareness.
Manual QA Engineer ensuring high - quality experiences in educational technology at Kira. Collaborating with product managers, engineers, and designers to validate new features and workflows.
Senior Manufacturing Engineer providing engineering capability for zero defect projects at GKN Aerospace. Delivering robust manufacturing processes and technical expertise while ensuring safety compliance.
QA Analyst maintaining product quality at Nestlé's Babelegi Factory. Coordinating sensory sessions and product release while ensuring compliance with quality standards.