Associate Director - Quality Assurance (MQA)

Tailstorm Health Inc-posted 11 days ago

Full-time • Director

Onsite • Chandler, AZ

101-250 employees

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The Associate Director of QA (MQA) ensures the implementation and maintenance of cGMP standards, oversees quality systems, and ensures that all manufactured products meet defined safety, identity, strength, purity, and quality requirements. This role provides leadership across compliance systems, investigations, documentation, internal audits, and regulatory readiness activities.

Ensure implementation and maintenance of current Good Manufacturing Practices (cGMP) and applicable international standards.
Ensure the product meets defined standards for strength, identity, safety, purity, and quality.
Review corrective and preventive actions (CAPA) aligned with complaints, deviations, and investigation root cause analysis.
Review and approve documents including the Site Master File, Validation Master Plan, SOPs, Master Batch Documents, and Validation Protocols.
Review and execute validation activities; provide recommendations aligned with regulatory expectations.
Guide and support departments during SOP reviews to strengthen the Quality Management System.
Review and approve OOS, OOT, Change Controls, Deviations, and ensure investigations use proper root‑cause tools.
Ensure implementation of Internal Quality Audit (IQA) schedules across manufacturing facilities.
Maintain audit readiness for regulatory authorities and partner audits.
Communicate and escalate concerns proactively, suggesting corrective and preventive actions.

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Microbiology, or related field.
10–15 years of progressive QA experience in sterile or regulated pharmaceutical environments.
Strong understanding of cGMP, QMS systems, audits, and regulatory expectations.
Experience leading investigations, root cause analysis, and CAPA effectiveness programs.
Proven ability to manage documentation systems and regulatory inspection readiness.

Experience in sterile injectables or aseptic manufacturing.
Experience with global regulatory inspections and client audits.
Strong communication and leadership capabilities.

Competitive salary based on experience.
Medical, dental, and vision insurance.
401(k) with employer match.
Paid time off, sick leave, and holidays.
Professional development and leadership‑growth opportunities.

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