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Qualified Person

Location Cork, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

Job Description

  • The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial and clinical product, in accordance with the requirements of EC/2001/83, EC2001/20 and Annex 16 and 13 requirements, as applicable.
  • The QP ensures all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP as stated in Directive 2003/94/EC and in the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2002.
  • Provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply of drug product
  • Routinely monitoring the company’s operations to ensure compliance with site Licenses and Good Manufacturing Practice bringing any critical and major deficiencies to the attention of the Head of Quality Assurance
  • Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement
  • Participates in cross functional teams as Quality/Qualified Person representative
  • Reviews and approves Product Quality Reviews

Experience/ Skills

  • Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
  • Biologics manufacturing experience highly desirable
  • Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable
  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required
  • Expertise in GxP and global regulatory requirements
  • Excellent training/mentoring experience
  • Excellent oral and written communication skills
  • Competent problem solving, risk assessment and impact analysis abilities

Requirements:

  • QP Qualification, with at least 8 years of Quality experience, in an EU licensed facility in a relevant functional area.
  • Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA)
  • Aseptic / Sterile Drug Product manufacturing experience essential
  • Experience with IMP's (Investigational Medicinal Products) desirable
  • Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations. 
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Cork

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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