Global Director of Quality and Regulatory

Axiota US Inc

20h•$160,000 - $180,000

About The Position

The Global Director of Quality and Regulatory is responsible for the strategic leadership and operational management of Quality Assurance and Regulatory Affairs across Warburton Technology's global operations. This role ensures compliance with GMP, GDP, and all applicable international and local regulations while driving the continuous improvement of the company's Quality Management System. The Director provides quality and regulatory oversight of manufacturing, distribution, and CMO activities, and partners cross-functionally with Operations, Supply Chain, and R&D to ensure a reliable, compliant supply of products to market.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Biosciences, or a related scientific discipline.
10+ years of progressive experience in Quality Assurance and/or Regulatory Affairs within a pharmaceutical or veterinary pharmaceutical environment.
Minimum 5 years in a leadership or management role with direct reports.
Deep working knowledge of GMP and GDP regulations (US, EU, and international).
Demonstrated experience with regulatory authority inspections and audit management.
Experience managing quality oversight of CMOs, including sterile manufacturing operations.
Strong understanding of Quality Management Systems (deviation, CAPA, change control, complaints, APQR).
Ability and willingness to travel
Willingness and ability to travel approximately 15%, both domestically and internationally, including visits to CMO partners and manufacturing sites.
Must be authorized to work in the United States without the need for current or future employer-sponsored visa support.

Responsibilities

Lead and develop the QA Operations team, setting goals, development plans, and providing regular coaching and performance management.
Develop, implement, and continuously improve the global Quality Management System in partnership with Global Operations.
Ensure compliance with international and local GMP and GDP regulations, guidelines, and internal policies across all manufacturing and distribution activities.
Provide quality oversight of EU and US contract manufacturers (CMOs) for sterile injectable products, including routine and qualification audits.
Provide quality oversight of GxP vendors including 3PL warehouses, logistics partners, distributors, and other service providers.
Ensure intermediate and finished products are manufactured in accordance with US, European, and ROW GMP requirements and applicable regulatory filings.
Author, review, and approve quality records including deviations, change controls, CAPAs, complaints, and APQRs.
Maintain inspection readiness and lead participation in regulatory authority inspections, self-inspections, management reviews, and mock recalls.
Develop and maintain quality metrics and reporting to support effective decision-making and compliance.
Monitor changes in the quality and regulatory landscape, ensuring internal and external stakeholders are informed and trained. Develop QA team competency to manage change and drive continuous improvement.
Identify and mitigate risks to product quality, supply continuity, or patient safety at CMOs or testing laboratories, escalating with proposed solutions as needed.
Lead Quality Management Review preparation and execution.
May act as a Responsible Person named on a Wholesale Dealers Authorisation.
Lead a team of regulatory specialists supporting trace mineral and broader product workstreams.
Manage regulatory submissions and interactions with FDA CVM, including INAD and NADA filings and CMC dossier preparation and review.
Oversee regulatory assessments and impact evaluations for changes initiated by CMOs or arising from internal product changes.
Monitor and manage annual license registrations for the US and all ROW markets.
Provide oversight for Pharmacovigilance processes and adverse event reporting obligations.
Provide project management guidance for the planning and timing of new market submissions and product registrations.
Stay current on evolving regulatory requirements across key markets and advise the organization on strategic implications.
Manage departmental budgets (Budget vs. Actual) across Quality and Regulatory functions, including oversight of invoicing and spending.
Provide strategic input to the COO on annual budget planning and attainment, ensuring departmental goals align with organizational financial objectives.