QA Systems & Compliance Associate - 12 Month Assignment
About this opportunity
<p>Who We Are <br /><br />BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.<br /><br />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.<br /><br />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. <br /><br />About Technical Operations <br /><br />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. <br /><br /></p><p><b><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">External QA Quality Associate – 12 month contract</span></b></p><p><b><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">QA Systems & Compliance</span></b></p><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;"> </span></p><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">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, CAPA’s, and Change Controls are consistently administered and in compliance with relevant Regulatory Standards</span></p><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;"> </span></p><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Key Responsibilities for this Role as follows;</span></p><ul style="margin-top: 0.0px;"><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">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.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Support development and implementation of digital improvement initiatives for External Quality.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Responsible for development/reporting of metrics and supporting standardization of these across the Organization.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Deliver training on Quality Management Systems within GEO, as required.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Identify and implement continuous improvement initiatives to the External Quality systems.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Participate in the change control program for modifications to qualified systems (within GEO).</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Assist as needed in audits and inspections.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Participate in development and implementation of global alignment projects with BioMarin’s sister sites.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Support the Self Inspection Programme for External Quality</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Other duties as assigned</span></li></ul><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;"> </span></p><p><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">The ideal candidate will have the following experience / skills:</span></p><ul style="margin-top: 0.0px;"><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Bachelor’s Degree in science or engineering</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Skilled in data analysis and excel. Power bi and AI tool’s experience desirable.</span></li><li><span style="font-size: 11.0pt;line-height: 115.0%;font-family: 'Open Sans' , sans-serif;">Strong communication and interpersonal skills – Oral, written and presentation skills</span></li><li>Works collaboratively with others to meet shared objectives</li></ul><p><br />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. <br /><br />Equal Opportunity Employer/Veterans/Disabled <br /><br />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.<br /><br /><br />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. <br />Ireland Safety Responsibility<br />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.</p>
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 249 comparable Associate Quality roles across 70 biopharma companies.
Salary context
52 of 249 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 249 comparable roles
+ 24 more countries
Seniority mix
249 of 249 peers have a known seniority level
Therapeutic area mix
0 of 249 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.