Who We Are
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.
Responsibilities
- Provide CSQA expertise and oversight of QC/BAS Analytical Instrument, Enterprise, Operations/Supply Chain and Quality computerized system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
- Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems and/or changes to existing validated computer systems.
- Provide guidance and support root cause analysis on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
- Apply Risk-based methodologies across the computerized system lifecycle.
- Provide guidance and QA oversight for SDLC documents like User Requirements, Specifications and Validation/Qualification protocols and test scripts.
- Responsible for the authoring and development of Periodic Reviews Reports for computerized systems across BioMarin.
- Provide quality oversight to support and follow BioMarin’s Data Integrity Program.
- Establish and sustain BioMarin’s computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Partnering with internal and external IM, QA, and Development Sciences teams; sharing information to increase the collective understanding of QA and Data Integrity programs.
- Knowledge of industry standards; 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at BioMarin.
- Ensuring alignment of processes, procedures, and methods across multiple organizations (internal and external).
- Authoring and/or revising SOPs.
- Authoring and/or revising validation documents and protocols.
- Administer applicable electronic systems.
- Assist as needed in audits and inspections.
- Contribute to projects related to CSQA improvements and system reliability.
- Development, execution, and approval of change control records.
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
Skills
- 3 to 5 years’ experience in CSV in the Life-science/regulated industry
- 3 to 5 years working in the Quality area in biotech or pharma
- Experience in Deviations, CAPAs, and Change Control Management
- Strong knowledge and implementation experience on industry regulations (e.g., 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance (e.g., ISPE GAMP, MHRA)
- Good knowledge and implementation experience on Data Integrity requirements (e.g., ALCOA & ALCOA+)
- Experience with Computer Systems Periodic Reviews
- Experience with Veeva QMS and Quality Docs
- Experience with Office 365
- Experience with SAP desirable
- Experience with ALM desirable
Education
- BS in a Computer Science or Engineering field or equivalent experience
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.
In the U.S, the salary range for this position is $ null to $ null per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors. In the U.S., the salary range for this position is $ null to $ null per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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