What are the responsibilities and job description for the Associate Director Quality Assurance position at 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
Bilingual: Preferred
Open Roles:
1. Associate Director, Quality Assurance – Pharma
Focus areas: Quality oversight for pharmaceutical manufacturing, formulation, filling, sterilization processes, contamination control, compliance, and regulatory readiness.
2. 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.
3. Associate Director, Quality Assurance – Surgery
Focus areas: Quality leadership for surgery product manufacturing, cGMP compliance, operational quality oversight, continuous improvement, and regulatory interactions.
4. Associate Director, Validation
Focus areas: Site validation program leadership, CSV, cleaning validation, process validation, facility/cleanroom validation, PM oversight, NPI, and technology transfer.
5. Microbiology Associate Director
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.
If you are a senior Quality, Validation, or Microbiology leader looking for your next opportunity in a global healthcare manufacturing environment, we would be happy to connect.
Please reach out or share your updated resume for a confidential discussion.