What are the responsibilities and job description for the Quality Assurance Strategist position at BioTalent?
Job Overview:
BioTalent is seeking a seasoned Quality Assurance professional to lead the Americas quality function. This role will be responsible for driving quality strategy, ensuring compliance with industry regulations and standards, and fostering a culture of quality and operational excellence.
Key Responsibilities:
- Lead the development and implementation of a comprehensive Quality Management System (QMS) across multiple sites in the Americas.
- Collaborate with cross-functional teams to drive continuous improvement in product quality, operational processes, and customer satisfaction.
- Oversee multi-site QA teams, ensuring they are well-structured, highly skilled, and aligned with corporate goals.
- Support business development activities, including due diligence for M&A targets and integration of newly acquired companies into the QMS.
- Lead major quality initiatives, risk-based assessments, and harmonization of quality processes across locations.
Qualifications:
- Bachelor's degree in engineering (Master's preferred).
- 10 years of experience in Quality Leadership roles.
- Strong expertise in quality systems compliance, including ISO 9001, ISO 13485, and 21 CFR 820.
- Proven track record in leading multi-site QA teams and driving strategic quality improvements.
