Operations Compliance Specialist

biomarin; Cork; On-site; EUR 60,000 - 85,000; Full time

Job summary

BioMarin International Ltd. is seeking an Operations Compliance Specialist to manage documentation, ensure GDP/GMP compliance, and support inspections across Manufacturing Operations.

Reporting to the Inspection Readiness Lead, you will author and update manufacturing docs, run data metrics, train colleagues, and coordinate cross-functional audit readiness.

Qualifications

• 2+ years in technical writing and compliance roles.
• Proficient data analytics and visualization.
• Strong knowledge of GMP, GDP and regulatory requirements.
• Experience in regulated healthcare environments.

Responsibilities

• Manage authoring and drafting of manufacturing operations documents.
• Maintain GDP/GMP compliance and support inspections.
• Produce and analyse QMS metrics and reports.
• Train colleagues on documentation systems and GDP queries.
• Coordinate with cross-functional teams to meet timelines.

Skills

Technical writing

Compliance

Data analytics

GMP/GDP

Regulatory knowledge

Job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

Manufacturing BioMarin International Ltd.

Title: Operations Compliance Specialist

Work Type: Contract 12 Months

Manufacturing BioMarin International Ltd.

The Role: Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist is responsible for all aspects of Documentation Management & Compliance including but not limited to the following main areas of responsibility of this role, which are as follows:

Document Management

• Manage the authoring & drafting of all types of Manufacturing Operations documentation.
• Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
• Support document updates and manage timelines for cross functional Projects.
• Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.
• Organise & Facilitate Document Round Table meetings with cross functional teams as required
• Mange and build Quality Veeva QMS metrics for Manufacturing Operations
• Coach & Train colleagues in Documentation System & GDP queries
• Support manufacturing operations on meeting deadlines on Veeva QMS records
• Update compliance procedures and processes.

Compliance Tasks

Generate Reports/Metrics & analyze trends as required including but not limited to:

Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics.

• Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.
• Train and perform Area Self Inspections & Generate ASI schedule.
• Train Manufacturing colleagues in GDP/GMP
• Management of Veeva paper Binders
• Continuous monitoring of Compliance in Manufacturing.
• Facilitate all internal and external Inspections.
• Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations.

Additional tasks:

• Collaborating with Global colleagues (as required) including but not limited to: Supplier Change Notifications, EDMS & Managerial Data Management
• Management of Job Descriptions & New Hire Checklist and Assigning Lockers.
• Be proactive & collaborative in troubleshooting & resolving issues with documentation,
• training & systems collaborating with different departments across the site.
• Engage in Continuous Improvement Initiatives
• Manage compliance projects and Inspection readiness updates.
• Apply aligned Operations Compliance Specialist role skills across Drug Substance, Drug Product and Packaging.

Requirements

• 2+ years’ experience in technical writing and compliance
• Proficient in data analytics, data visualization
• Working knowledge in Regulations, GMP, GDP
• 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
• Strong verbal, written and oral communication skills.
• Able to work independently and be flexible to changing priorities

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.