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QA CMO Associate (TEMPORARY)

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. 

 This person is to provide QA support for external contract manufacturing operations


Assist with the oversight of the supply chain, manufacture and packaging of BioMarin products in various Contact Manufacturing Organizations.

Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending batch release.

Review and approve standard operating procedures, master batch records and product specifications.

Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.

Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.

Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.

Assist with regulatory inspections.

Artwork Approval

Support the following activities, as appropriate:

Processing external customer complaints

Quality Deviations and Laboratory Investigations

Change Controls

New or updates to relevant quality agreements

Validation activities

Perform Audits internal & external

Annual Product Reviews

Recalls and/or notification of events to regulatory agencies

Skills
A minimum of 5 years’ experience in a cGMP regulated drug substance, drug product manufacturing and/or packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.


Ability to comprehend technical information related to equipment, processes, and regulatory expectations.


Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.


Ability to speak, present data, and defend approaches in front of audiences and inspectors.


Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations. 


Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO’s.


Note: This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned

Education
Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, 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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