Director, Quality Assurance Operations

BioTalent Ltd; Georgia; On-site; USD 120,000 - 160,000; Full time

Job summary

BioTalent Ltd is seeking a Director of Quality Operations to lead and evolve site-wide quality systems in the United States, Georgia. This senior leadership role emphasizes operational excellence, compliance, and quality transformation in the life sciences sector. The candidate will oversee quality management systems, lead audits, and mentor a high-performing team ensuring quality across products and regions. The position offers significant influence on strategic direction and visibility with executive leadership, making it essential for shaping quality standards in a high-growth environment.

Qualifications

• Proven leadership in relevant industries.
• Deep expertise in Quality Management Systems and regulatory compliance.
• Strong track record of quality transformation.

Responsibilities

• Own and optimise the site Quality Management System (ISO 9001 / 13485 / cGMP).
• Lead CAPA, non‑conformance, audit, and inspection frameworks.
• Drive continuous improvement across quality operations.

Skills

Leadership in pharma, biotech, or medical device manufacturing

Expertise in QMS, audits, CAPA, and regulatory compliance

Driving quality transformation in scaling environments

Influencing at senior level

Cross-functional collaboration

Job description

We’re partnering with a rapidly scaling, global life sciences manufacturer investing heavily inquality, compliance, and operational excellence.

They’re hiring aDirector, Quality Operationsto lead and evolve site‑wide quality systems, drive performance, and build a best‑in‑class quality function.

The Role

• Own and optimise thesite Quality Management System (ISO 9001 / 13485 / cGMP)
• LeadCAPA, non‑conformance, audit, and inspection frameworks
• Overseehigh‑risk investigations and product quality decisions
• Drivecontinuous improvement across quality operations
• Lead, mentor, and scale ahigh‑performing quality team
• Partner cross‑functionally to ensurequality at scale across products and regions

What They Need

• Proven leadership inpharma, biotech, or medical device manufacturing
• Deep expertise inQMS, audits, CAPA, and regulatory compliance
• Strong track record ofdriving quality transformation in scaling environments
• Ability to influence at senior level and operatecross‑functionally

Why This Role

• Senior leadership role with direct impact onglobal quality performance
• Opportunity to shape and scalequality systems in a high‑growth environment
• Visibility with executive leadership and influence overstrategic direction