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Director of Quality Assurance Leadership

BioTalent
Hopedale, MA Full Time
POSTED ON 4/5/2025
AVAILABLE BEFORE 5/2/2025

Company Overview

BioTalent is a leading organization dedicated to driving quality and operational excellence across multiple sites in the Americas. Our commitment to regulatory standards (ISO 9001, ISO 13485, 21 CFR 820) sets us apart as a trusted partner.

Key Responsibilities

  • Lead the Americas Quality Assurance function, aligning quality initiatives with our overall business strategy and objectives.
  • Develop and implement a comprehensive Quality Management System (QMS) across multiple sites, ensuring compliance with industry regulations and standards.
  • Collaborate with cross-functional teams and key stakeholders 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.
  • Act as a key representative for regulatory audits and compliance-related activities.

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