Associate Director, Quality Assurance

ClinicalPro is seeking an Associate Director, Quality Assurance for a leading organisation specialising in Small Molecule research located in the USA.

This individual will be responsible for handling and managing operations related to batch disposal, quality systems, and QA monitoring.

Must be eligible to work in the USA.

Responsibilities

• Leading quality control over GMP testing and production operations.
• Review and approve GMP documentations.
• Create, route, approve, and track GMP documentations in the QMS system in collaboration with cross-functional teams (Pharmaceutical Development, Regulatory, Supply Chain, etc.). This includes change controls, deviations, CAPAs, complaints, audit results, etc.
• Examine regulatory filing paperwork like the IND and IMPD.
• Organise the GMP paperwork produced by CMOs.
• Make sure the electronic document system has these papers up to date and comprehensive.
• Knowledge of quality.
• Oversee the quality systems.
• Accountable for adhering to the requirements and criteria set by the health authority. operates in accordance with global GMP guidelines.
• More tasks as needed.

Skills and Requirements

• A Bachelor’s degree in life sciences.
• 10+ years of experience working in the industry.
• Extensive scientific expertise (small molecules preferred) and quality management expertise,
• Dealing with CMOs and monitoring their quality documentation.
• It is desirable to have prior knowledge of electronic quality documents and QMS system.
• Good communication skills.
• Ability to work together in a team.
• Excellent understanding of all GMP-related regulatory requirements.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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