Associate Director, Quality Systems & Operational Readiness, External Quality

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.
Associate Director, Quality Systems & Operational Readiness, External Quality

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.
SUMMARY DESCRIPTION

The Associate Director, Quality Systems & Operational Readiness reports to the Executive Director, External Quality. This role has four major areas of responsibility: 1) leading BioMarin's Quality Assurance oversight Technology Transfers and Operational Readiness within Global External Operations (GEO), 2) providing Quality Validation oversight for all process, packaging and shipping validation activities within GEO while collaborating with BioMarin's MSAT, GEO, Engineering and Contract Manufacturers (CMO's), 3) lead the oversight and management of the Quality Systems that support the External Quality and GEO GMP practices and 4) set strategic vision for the department and lead a team of skilled professionals to complete responsibilities within the department.
The Associate Director, Quality Systems & Operational Readiness will lead a team that works collaboratively with other Site & Global Quality functions as well as with Global External Operations to ensure effective communications and oversight of CMO operations. The incumbent is expected to work with cross functionally to resolve issues, improve relevant business processes and systems.
The Associate Director, Quality Systems & Operational Readiness will report to the Executive Director Global Quality, External Manufacturing and Supply. This position will sit on the External Quality Leadership Team.
SCOPE
People Leader, with a team of ~5 people, in multiple global locations and time zones, all working to make quality product for patients in clinical trials.
The responsibilities in the role include the following:

• Oversight of Technology Transfer of processes to and from Contract Manufacturing Organizations.
• Ensuring GMP and Operational readiness of new CMO's and New Product Introductions into CMO's.
• Provide QA oversight of Process Validation activities at CMO's.
• Lead and host the Quality System Governance process and meeting for External Quality.
• Monitor and assess impact to BioMarin's Quality System of all government regulations, guidance, and expectations as they pertain to manufacturing, packaging, labelling and shipping processes within Global External Operations.
• Maintain current knowledge of industry standards and commercial manufacturing, packaging and shipping solutions for products developed and manufactured by BioMarin.
• Ensure alignment of processes, procedures and methods across multiple organizations (internal and external).
• Establish and sustain BioMarin's global policies and standards that incorporate industry best practices and are health authority compliant to conduct the design, development, qualification, and implementation of packaging & labelling processes & shipping methods for BioMarin's products.
• Ensure systems are fully implemented and integrated with other quality management systems, CMO systems, and GSC systems.
• Lead continuous improvement initiatives based on user feedback, process monitoring results, observations, and responses.
• External Quality representation during Quality Metric Governance meetings, and business forums including site leadership teams.
• Ensure QA staff training and development.

This position will interact with other departments throughout the organization. This position will partner with and influence Quality, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as required. This position requires constant contact with Senior Management across the organization.

Role is based in Novato, CA and is hybrid workstyle. We define hybrid as 2-4 days per week onsite.

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.

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.