QA Systems & Compliance Associate – 12 Month Assignment

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

BioMarin Pharmaceutical Inc. seeks an External QA Quality Associate to support the Quality Systems program within External Quality, ensuring deviations, CAPAs and change controls are administered in compliance with regulatory standards.

The role reports to the Associate Director, External Quality, Quality Systems & Compliance and will drive digital improvement initiatives, governance, metrics and audits across GEO in Ireland. 12-month contract in Cork.

Qualifications

• Bachelor's Degree in science or engineering required.
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Strong data analysis and Excel skills; Power BI and AI tools desirable.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive timely closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control with leadership endorsement.
• Develop/report metrics and support standardization across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meetings for GEO.
• Deliver training on Quality Management Systems within GEO as required.
• Collaborate with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in change control program for modifications to qualified systems (within GEO).
• Assist in audits and inspections as needed.
• Participate in global alignment projects with BioMarin's sister sites.
• Support the Self Inspection Programme for External Quality.
• Other duties as assigned.

Skills

Data analysis

Excel

Power BI

Oral and written communication

Interpersonal skills

Education

Bachelor's Degree in science or engineering

Tools

Power BI

AI tools

Job description

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

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.

External QA Quality Associate - 12 month contract

QA Systems & Compliance

This position reports to the Associate Director, External Quality, Quality Systems & Compliance. The main responsibility of this role is supporting the Quality Systems program within External Quality ensuring key Quality System elements such as Oversight, Deviations, CAPAs, and Change Controls are consistently administered and in compliance with relevant Regulatory Standards

Key Responsibilities for this Role as follows;

• Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Responsible for development/reporting of metrics and supporting standardization of these across the Organization.
• Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO, as required.
• Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to the External Quality systems.
• Participate in the change control program for modifications to qualified systems (within GEO).
• Assist as needed in audits and inspections.
• Participate in development and implementation of global alignment projects with BioMarin's sister sites.
• Support the Self Inspection Programme for External Quality
• Other duties as assigned

The ideal candidate will have the following experience / skills:

• Bachelor's Degree in science or engineering
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
• Skilled in data analysis and excel. Power bi and AI tools experience desirable.
• Strong communication and interpersonal skills - Oral, written and presentation skills
• Works collaboratively with others to meet shared objectives

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.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.