Quality Assurance Operations Manager

About this job :

The QA Manager will be responsible for overseeing quality systems and supporting day-to-day operational execution within a fast-paced biotech environment. This role ensures that processes supporting the development and manufacturing of recombinant plasminogen for diabetic foot ulcer treatment meet all relevant GMP, regulatory, and internal standards.Key Responsibilities :

Quality Assurance :

• Ensure compliance with EU / FDA GMP regulations and relevant ICH documentation standards.- Draft, review, and maintain SOPs, work instructions, and other quality documents.- Manage internal audits and assist in the coordination of external GMP and vendor audits.- Provide QA oversight for CMOs and third-party providers.- Contribute to batch record reviews, manage deviations, CAPA, change control, and oversee document control activities.- Develop and sustain a robust Quality Management System (QMS) for early-stage biologics (from preclinical to early clinical phases).Operations Management :
• Support clinical trial material (CTM) production readiness and preparation of IMPD and other CMC documentation.- Monitor project timelines, coordinate resource planning, and align with operational budgets.- Work cross-functionally with R&D, regulatory, and manufacturing teams to maintain operational documentation.- Review and evaluate manufacturing protocols and Batch Manufacturing Records (BMR).- Assist with tech transfer and scale-up processes alongside external manufacturing partners.Compliance Responsibilities :
• Implement and maintain quality systems in accordance with regulatory expectations.- Ensure ongoing GMP compliance across all quality and operational processes.- Oversee vendor qualification and ongoing management.- Enable IP and regulatory readiness, and support legal and ethical standards.Candidate Profile :
• 3+ years of experience in Quality Assurance and / or Operations within biotech or biopharma, preferably in a start-up or scale-up environment.- In-depth understanding of cGMP practices and EMA / FDA regulatory frameworks and documentation expectations.- Background in working with biologics, such as recombinant proteins, cell therapy, or gene therapy.- Experience with eCTD Module 3 documentation requirements.- Proven ability to manage third-party vendors and CMOs and implement QMS in a fast-moving setting.- Bachelor's or Master's in Biotechnology, Pharmacy, Life Sciences, or a closely related field.- Fluent in spoken and written English;

other languages are beneficial.Soft Skills :