Manager, R&D Quality Operations

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately owned specialty pharmaceutical company dedicated to developing innovative products that address the needs of underserved patient populations. Renowned for offering distinctive, accessible, and high-quality medications, Azurity relies on its integrated expertise and extensive partner network to continuously broaden its comprehensive commercial product portfolio and advancing pipeline in late-stage development. Serving markets including cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan diseases, Azurity's products have positively affected millions of lives. The company values inclusivity, equal opportunity, and attributes its success to a talented, committed team driven by scientific excellence and quality.

Role Overview

The Manager of R&D Quality Operations will oversee the quality assurance aspects of product development and technical product releases. This entails ensuring that quality management system (QMS) documents are complete, accurate, and suitable for maintaining product quality standards.

Key Responsibilities

• Developing and reviewing quality assurance standard operating procedures (SOPs) and collaborating on SOPs related to formulation, analytical development, regulatory affairs, IT, and research & development.
• Evaluating and approving change controls, deviations, out-of-specification reports, and laboratory investigation reports.
• Assessing batch records and authorizing technical batch releases for market distribution.
• Reviewing and authorizing risk management procedures such as Failure Mode and Effects Analysis (FMEA).
• Managing the quality aspects within the stage gate product development process.
• Providing senior management with quarterly quality metrics related to contractors.
• Ensuring vendor and contractor qualifications through questionnaires, audits, and quality technical agreements.
• Finalizing quality agreements with contracted organizations and suppliers as applicable.
• Overseeing training completion to guarantee personnel perform only authorized tasks.
• Maintaining audit-ready QMS documentation at all times.
• Ensuring product adherence to Quality System Regulation (QSR) and 21 CFR 820 requirements through design control support.
• Supporting risk management by monitoring current controls and identifying any residual product risks.
• Reviewing and approving protocols and reports for process validation, analytical method validation, method transfers, microbiological tests, stability studies (photostability, freeze-thaw), optimization studies, sampling, and hold time studies.
• Approving specifications and reports related to technology transfer activities.
• Providing feedback assessments on client or customer quality management documents, including change controls, deviations, and out-of-specifications, specifically for contract organizations.
• Reviewing product development reports and specifications for products made at contract development sites.
• Ensuring all incoming materials used by contractors come from approved vendors.
• Conducting audits and certification of contract research organizations (CROs), contract manufacturing organizations (CMOs), and active pharmaceutical ingredient sites linked to Azurity projects.

Required Experience and Skills

• A minimum of 12 to 15 years of experience performing quality assurance responsibilities within pharmaceutical product development.
• Strong verbal and written communication skills with clarity in executing tasks.

Educational Qualification

Possession of a master's or bachelor's degree in a scientific discipline is preferred.

Additional Information

Applicants must confirm they are mentally and physically capable of performing the stated duties without restrictions. Any concerns or disabilities should be disclosed to Human Resources prior to acceptance.