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Join our client with this QA position and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity. Proclinical is seeking a Senior QA Specialist (CMO Oversight) to support QA vendor oversight activities, ensuring compliance with cGMP standards and quality systems. This role involves managing contractor relationships, reviewing quality documentation, and overseeing product quality processes for commercial bulk and finished drug products. Occasional travel may be required.
Job Responsibility:
Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements
Build and maintain strong working relationships with contractors
Lead discussions on quality-related topics such as complaints, change control, deviations, and documentation
Recommend and oversee quality-related improvements at contractor sites
Review batch records, including master production-packaging records and executed batch records, for GMP compliance
Manage and monitor change control requests, including evaluation, approval, and progress tracking
Support and approve complaint investigations related to external vendors
Review, edit, and approve contractor documentation, including validation protocols, reports, and investigations
Lead the review of Annual Product Quality Review reports and negotiate improvements with contractors
Draft, review, and recommend approval for Quality Agreements
Participate in self-inspections and external audits of contractors as assigned
Maintain logs, databases, and files related to product quality activities
Perform trend reviews and compile metrics
Develop and maintain pharmaceutical quality systems, author or revise SOPs, and provide recommendations on policies and standards
Support GMP/GDP site inspections and ensure compliance with personal training requirements
Requirements:
Strong knowledge of cGMP/GDP regulations for the USA, EU, and international markets
Ability to balance business targets with scientific and quality decisions
Excellent analytical, problem-solving, and project management skills
Strong communication and organizational abilities
Experience in developing and executing pharmaceutical quality systems
Proficiency in computer systems
Degree in a scientific discipline (BSc or equivalent)
Technical expertise in chemical, biological, and/or pharmaceutical operations
Experience interacting with Health Authorities (e.g., FDA, EMA) and supporting inspections
Proven ability to manage quality at external manufacturing sites