What are the responsibilities and job description for the Senior Manager, R&D Quality – Document Control & Training position at BioSpace?
Who We Are
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.
We are seeking a Senior Manager, R&D Quality – Document Control & Training to lead and continuously improve critical GxP quality system processes supporting our R&D organization. This role is responsible for document lifecycle management, training governance, inspection readiness support, process standardization, metrics/reporting, and cross-functional quality systems partnership.The ideal candidate brings strong experience in controlled document management, training administration/governance, and GxP quality systems within biotech, pharma, or life sciences. This is a highly collaborative role requiring partnership across Quality, Clinical, Nonclinical, Regulatory, Safety/Pharmacovigilance, and other stakeholders to ensure compliant, scalable, and efficient processes.What you’ll do
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.
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.
We are seeking a Senior Manager, R&D Quality – Document Control & Training to lead and continuously improve critical GxP quality system processes supporting our R&D organization. This role is responsible for document lifecycle management, training governance, inspection readiness support, process standardization, metrics/reporting, and cross-functional quality systems partnership.The ideal candidate brings strong experience in controlled document management, training administration/governance, and GxP quality systems within biotech, pharma, or life sciences. This is a highly collaborative role requiring partnership across Quality, Clinical, Nonclinical, Regulatory, Safety/Pharmacovigilance, and other stakeholders to ensure compliant, scalable, and efficient processes.What you’ll do
- Lead controlled document and training processes in a GxP-regulated environment
- Drive process improvements across document control, training, and quality systems workflows
- Support audit and inspection readiness activities
- Monitor and trend quality system metrics and identify opportunities for improvement
- Partner cross-functionally to improve compliance, standardization, and operational effectiveness
- Provide subject matter expertise on document control and training systems/processes
- Experience in Quality, Quality Systems, Compliance, or related functions in biotech/pharma/life sciences
- Strong experience with document control and training processes in a regulated environment
- Knowledge of GxP requirements relevant to R&D/development organizations
- Ability to work cross-functionally and influence in a matrixed environment
- Experience supporting inspections, audits, and continuous improvement initiatives
- Direct experience with Veeva Vault
- Direct experience with ComplianceWire
- Experience in R&D, clinical, nonclinical, or development-phase quality environments
- Experience with metrics, reporting, and process harmonization
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.