Assistant Director of Validation & QMS- QA

Tailstorm Health Inc•Chandler, AZ

13d•Onsite

About The Position

The Assistant Director of Validation & QMS will lead validation strategy, quality systems oversight, sterility assurance programs, and regulatory compliance for sterile injectable manufacturing. This role provides leadership across validation activities (process, equipment, utilities, cleaning, aseptic qualification), and ensures robust QMS execution including change control, deviation management, CAPA programs, investigations, and audit readiness. The position is responsible for driving continuous improvement, maintaining cGMP compliance, and supporting validation lifecycle activities aligned with FDA, EU, and global standards.

Requirements

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Microbiology, or a related scientific discipline.
10–15 years of progressive experience in Validation, QMS, and sterile injectable manufacturing.
Expert knowledge of validation methodologies including equipment, utilities, cleaning, aseptic, and process validation.
Strong understanding of cGMP, FDA, EMA, and global quality guidelines.
Proven ability to lead cross-functional teams and manage large-scale validation programs.
Hands-on experience with QMS tools/software and strong documentation skills.

Nice To Haves

Experience working in 503B, sterile injectables, or aseptic pharmaceutical manufacturing environments.
Advanced knowledge of lifecycle validation and risk management (ICH Q9/Q10).
Experience leading regulatory inspections (FDA, MHRA, EMA, WHO).

Responsibilities

Lead planning, execution, and approval of media fill studies ensuring robust aseptic process simulation performance.
Oversee area qualification activities for classified cleanrooms (Grade A–D), including requalification and EM compliance.
Provide technical leadership for IQ/OQ/PQ protocols, equipment validation, and approval processes.
Oversee validation of critical utilities including HVAC, WFI, compressed air, and clean steam.
Lead development, review, and approval of cleaning validation strategies, acceptance criteria, and reports.
Direct process validation activities, including protocol design, execution oversight, and statistical analysis for process capability.
Ensure validation activities align with risk-based approaches, lifecycle validation principles, and global regulatory expectations.
Provide strategic leadership for QMS elements including change control, deviation management, CAPA, and complaint investigations.
Oversee timely closure of deviations, effective root cause analysis, and ensure documented evidence of corrective actions.
Ensure robust CAPA effectiveness checks and continuous improvement mechanisms.
Lead OOS/OOT investigations and ensure scientifically sound root cause analysis and preventive actions.
Maintain compliance with FDA, EU, ICH, and internal quality requirements.
Support and lead internal and external audits, including regulatory inspections, vendor audits, and customer audits.
Ensure robust documentation practices and compliance with data integrity principles.