Alcott Global

We are hiring multiple Associate Director-level Quality leaders for a leading global organization in the pharmaceutical and medical device manufacturing sector.

Location: Texas, USA, (Relocation within Texas may be required, and further location details will be shared at the appropriate stage of the process)

Sector: Pharmaceutical / Med Tech Manufacturing

Level: Associate Director

Open Roles:

Associate Director, Quality Assurance - Pharma

Focus areas: Quality oversight for pharmaceutical manufacturing, formulation, filling, sterilization processes, contamination control, compliance, and regulatory readiness.

Associate Director, Quality Assurance - Vascular

Focus areas: End-to-end quality oversight for vascular product manufacturing, shop-floor quality, investigations, CAPA, change control, risk management, and inspection readiness.

Associate Director, Quality Assurance - Surgery

Focus areas: Quality leadership for surgery product manufacturing, cGMP compliance, operational quality oversight, continuous improvement, and regulatory interactions.

Associate Director, Validation

Focus areas: Site validation program leadership, CSV, cleaning validation, process validation, facility/cleanroom validation, PM oversight, NPI, and technology transfer.

Focus areas: Microbiology, contamination control, environmental monitoring, sterility assurance, water systems, incoming materials testing, chemical laboratory oversight, and data integrity.

What we are looking for:

The ideal candidates will bring strong experience in pharmaceutical and/or medical device manufacturing, with a proven track record in quality, validation, microbiology, laboratory operations, regulatory compliance, and people leadership.

Key requirements include:

• 10+ years of relevant experience in Quality, Validation, Microbiology, Laboratory Operations, Pharmaceutical Manufacturing, Biotech, or Medical Device Manufacturing
• 5+ years of leadership experience managing teams, programs, or site-level quality functions
• Strong knowledge of FDA, EU GMP, ISO 13485, cGMP, 21 CFR 210/211/820, Annex 1, and data integrity expectations
• Experience supporting regulatory inspections and interactions, including FDA inspections, 483s, and warning letter responses
• Strong ability to lead cross-functional teams, drive accountability, strengthen compliance culture, and support operational excellence
• Pharmaceutical manufacturing experience is strongly preferred or required for select roles
• Bilingual proficiency is preferred

These are strategic site leadership roles with high visibility and strong impact across manufacturing, quality systems, compliance, validation, and regulatory readiness.