The Qualified Person is responsible to ensure that licensed Finished Product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001 / 83 / EC, 2004 / 94 / EC and in accordance with the requirements of Annex 16.
To ensure that investigational medicinal product (IMP) is certified and released to sponsor by a Qualified Person named on the IMP Manufacturing License in accordance with EU directive 2001 / 20 / EC and in accordance with the requirements of Annex 16 and Annex 13.
Job Duties & Responsibilities
QP release of Alexion products across the across the Alexion network and contract manufacturing operations to ensure commercial and clinical drug substance, drug product and finished products are certified in accordance with GMP and MA / IMPD to support patient supply for rare diseases
QP Partner with Finished Product Operations team and Drug Substance for on time release
Ensure independence of the QP on decisions on quality related matters.
Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements.
Provide quality and compliance guidance on all critical and major quality matters managed by Alexion Ireland.
Ensure QP quality review and approval for Annual Product Quality Review
Creates an environment for right first time’ in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective
Support Regulatory Inspections and be a representative of Alexion in front of Health Authorities and Regulatory Bodies
Provide audit support as required for internal auditing program and supplier audits.
Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
Responsible for people management for direct reports
Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice
Minimum 10 years GMP related experience in biopharmaceutical / pharmaceuticals.
Eligible and demonstrated ability to act as Qualified Person within EC / EEA.
Minimum 3 years QP experience
Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach.
Extensive demonstrated pharmaceutical quality experience.
Must have thorough knowledge of biopharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP / GDP requirements.
Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
Must have strong task management skills with the ability to prioritize, schedule, and control under tight deadlines.
Demonstrated ability to be a Quality Leader, driving Right First Time culture whilst ensuring compliance
Preference given to candidates with advanced degrees; eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
Dublin , Ireland
Some opportunities happen only once in a lifetime like a job where you have the extraordinary opportunity to change lives.
At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases.
These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.