Manager, QA Operations

About the company

Azurity Pharmaceuticals is a privately held specialty pharmaceutical organization that develops innovative medicines for patient groups that are often underserved. The company is known for accessible, high-quality products and uses its integrated strengths and partner ecosystem to keep growing its commercial portfolio and late-stage pipeline. Its offerings serve cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan therapy areas, and the company states that its products have helped millions of patients.

Azurity describes itself as an inclusive employer and an equal opportunity workplace. It emphasizes hiring people who are motivated, principled, and creative, and who are committed to improving patient outcomes through strong science and a quality-focused mindset.

Role overview

The Manager, QA Operations will be responsible for carrying out international quality assurance operations to help ensure compliance with US FDA, EU GMP, Health Canada, PIC/S, and GDP requirements. The position also supports global quality activities such as deviation and OOS reviews, CAPA handling, change control, product quality reviews, complaint management, vendor audits, and technical batch release activities where applicable.

Key responsibilities

• Provide QA oversight for assigned CMOs, 3PLs, and other international vendors, including review of deviations and out-of-specification events, change control, and CAPA assessments.
• Prepare and review technical documents needed for batch disposition, such as batch record checks, certificates of analysis, deviation and investigation reports, and stability-related evidence to support product release in market.
• Make sure quality systems and procedures comply with international standards as well as local country requirements.
• Work closely with Supply Chain, Regulatory, and Technical Operations teams to ensure smooth supply of medicinal products across different markets.
• Manage vendor quality systems activities, including deviation investigations, CAPA follow-up, change control oversight, product quality reviews, compliance risk assessments, self-inspections, and quality technical agreements.
• Support inspections conducted by local health authorities and track corrective follow-up actions.
• Assist with GMP and GDP audits of CMOs, 3PLs, and other vendors when needed.
• Take part in local risk management and escalation activities that follow global procedures.
• Drive ongoing improvement initiatives and help train QA team members on regulatory and compliance expectations.

Experience and qualifications

The role requires at least 5 years of experience in pharmaceutical quality assurance or QA operations. Candidates with QC experience may also be considered. Prior hands-on experience managing external pharmaceutical manufacturers is expected. Familiarity with Veeva Quality Vault or another quality management system is considered an advantage.

A degree in pharmacy, chemistry, biology, or another related science discipline is preferred.

Additional declaration

Applicants confirm that they are mentally and physically able to perform the duties described for this position without restrictions. If there are any concerns, including even a minor disability that could affect job performance, the candidate is expected to inform HR in advance.