Technical Manager, Global Quality Systems
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
This position reports to the Associate Director of Quality Systems and Issue Management, and will manage Product Complaint records within the Commercial and Clinical Product Complaint System. This position will also contribute to the compiling and drafting of Annual Product Reviews as well as data and metrics gathering to support the quarterly Quality Systems Management Reviews
The main areas of responsibility of this role are as follows:
Maintain QA oversight for interactions with a variety of functional departments to complete Product Complaint Investigations
Represent Quality Assurance in multi-departmental meetings & project teams
Support drafting of Annual Product Reviews and Quality System Management Reviews
Assist in the implementation of Product Complaint policies, and continuously evaluate and improve practices and systems
Support Regulatory inspections as well as internal and partner audits with regard to product complaints, APR and QSMR processes.
Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin; proactively incorporate anticipated changes into related procedure to stay in sync with the latest requirements
Other duties as assigned
The ideal candidate will have strong decision making, collaboration, communication, and leadership skills and a background in biopharmaceutical manufacturing and quality systems.
7+ years of experience in a GMP regulated environment.
Proven comprehension of technical information and regulatory expectations.
Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
Exhibited proficiency working within quality systems.
Ability to successfully communicate with representatives from all levels within the organization.
Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
Experience with TrackWise, Veeva Vault, Oracle systems or Power BI a plus.
BA or BS in a technical discipline (physical or biological sciences preferred).
This position does not utilize any specific equipment.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.