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Quality Assurance Operations Manager

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United Kingdom, Ireland

Offer summary

Qualifications:

Degree in science; 7+ years in biopharmaceuticals, MSc in Industrial Pharmaceutical Science preferred, 3+ years supervisory experience in manufacturing, Experience in aseptic filling and sterilisation, Track record in audit and regulatory management.

Key responsabilities:

Ensure compliance with product quality standards
Oversee adherence to EU GMP and FDA regulations
Perform checks, tests, and quality documentation
Update teams on technical advancements
Collaborate with global QA and operations teams

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

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Job description

Our client are seeking an experienced and seasoned QA professional in Ireland to join their flagship Biologics manufacturing facility as Quality Assurance Operations Manager. This is a crucial role where you will be responsible for leading and oversight of the production of sterile products, ensuring compliance with regulatory standards and company requirements. You will also be responsible for building and managing the quality team to adhere to GMPs and implement strategic improvements to the quality system for both commercial and new products.

Key Responsibilities:

Ensure aseptic products meet user, regulatory, and company standards.
Oversee manufacturing compliance with EU GMP Annex 1 and FDA regulations.
Perform necessary checks, tests, and documentation for quality control.
Keep QA and Operations teams updated on technical and scientific advancements.
Collaborate with global Quality Assurance, Regulatory groups, and RD teams.
Work with QA Director and Quality Control to achieve customer, quality, regulatory, and financial goals.

Qualifications:

Degree in a science discipline with 7+ years in biopharmaceutical/pharmaceutical industry.
Preferred: MSc in Industrial Pharmaceutical Science for Qualified Person (QP) status.
3+ years supervisory/managerial experience in Manufacturing within Biotechnology, Pharmaceutical, or medical device sectors.
Experience in drug product manufacturing processes, including aseptic filling and sterilisation operations.
Proven track record in audit and regulatory interaction management.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/c2423310a43a48acf93a77676aa4aaf8