Overview
Quality Manager – Newcastle Jobs in Milford, Delaware, USA at BioTalent
Overview:
The
Quality Assurance
(QA) Lead, reporting to the Senior Director of Global Quality and Operations, will manage a team of QA professionals responsible for planning and executing quality-related projects across multiple facilities. This individual will
lead initiatives
to improve product and process quality, analyze quality metrics (e.g., customer complaints, process non-conformances, capability data), and drive
continuous improvement
efforts. The ideal candidate will bring a
proven track record
in building and leading high-performance QA teams, with a strong emphasis on
regulatory compliance
and customer
Responsibilities:
Lead strategic quality initiatives in alignment with organizational objectives and applicable regulatory standards
Develop, implement, and oversee quality systems to ensure high product quality and compliance
Drive best practices for
process improvement
, root cause analysis, and
customer satisfaction
Serve as the Management System Representative Manage and enhance quality management system elements, including document control, CAPA, internal/external audits, training, supplier quality, and
change management
Ensure conformance with applicable quality and regulatory standards (e.g., ISO certifications) across all operational areas
Develop and monitor quality performance metrics, provide analysis, and present results to
senior leadership
Maintain and administer the corrective/preventive action and non-conformance processes
Oversee and lead internal audit programs aligned with ISO and regulatory standards
Guide
continuous improvement
projects that emphasize product and process enhancements
Lead, mentor, and coach the QA team to achieve operational and professional excellence
Qualifications:
Education:
Minimum:
Bachelor’s degree in Engineering (e.g., Electrical, Mechanical, Chemical) or a scientific discipline with strong statistical emphasis
Preferred:
Advanced degree
Experience and Skills:
At least 10 years in
Quality Assurance
or a related field within a regulated industry
Minimum of 5 years in a
leadership
role overseeing a Quality Management System (QMS) in an ISO-certified environment
Certified Lead Auditor (ISO 9001) required
Familiarity with ISO 9001 and ISO 17025 standards required
Strong
project management
, organizational, analytical, and
problem-solving skills
Experience leading third-party audits and ensuring compliance with regulatory bodies
Excellent interpersonal and
communication skills
Preferred certifications:
Six Sigma (Black or Green Belt), PMP, CAPM, or equivalent
Title: Quality Manager – Newcastle
Company: BioTalent
Location: Milford, Delaware, USA
Category: Quality Assurance – QA/QC, Management
