Jobs and Careers

Associate Director, Quality Validation

United Statesfull_timeVerifiedPosted 12 Aug 2024

About the role

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.

SUMMARYThe Associate Director, Quality Validation is a highly motivated technically knowledgeable leader with proven abilities to lead quality validation and engineering and promote continuous improvement and efficiencies through the application of lean strategies that are compliant with regulations and industry standards. The Head of Quality Validation is part of the Novato Quality Leadership team (NQLT), reporting to the Site Head of Quality. Our company was founded in Novato, California nearly 30 years ago. This leader will provide strategic direction for the Novato Site Validation, establishes clear expectations, goals, and metrics and is accountable for the quality oversight of all validation activities at the Novato site. The scope of the validation oversight includes facility, utility, equipment, automation qualification/validation activities and process validation activities supporting the Novato site manufacturing and testing. The position is an integral part of Novato operations and a key partner to Engineering and Facility Services by providing guidance and quality oversight for the design and/or changes to facility, utility, equipment, automation. This leader will hire, develop, and retain a high performing team, highly skilled in quality and compliance, driving excellence in Quality and productivity; effectively implement new quality technologies and create an environment where our people will be engaged, grow, and thrive displaying a strong quality culture.This position requires a broad range of knowledge and experience with biologic processes, quality engineering and validation and understanding of the international regulatory landscape. Key Responsibilities

Direct validation process improvements and goals using current regulations and demonstrated best practices. Continuously monitor industry trends and changes in regulations.
Provide direction and leadership to the quality validation department, to the site and globally in establishing validation strategies based on industry best practices and regulatory expectations.
Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
Establish appropriate metrics to monitor the various validation activities that drive efficiencies.
Responsible for providing quality assurance oversight for all validation related activities.
Responsible for the integration of risk management program in validation activities.
Establish effective partnership with the following key cross-functional groups to ensure a streamlined and effective validation program:

Global Quality Assurance
Novato Facilities and Engineering
TDS (MSAT)
QC (Quality Control)
IT (Information Technology)
Quality Operations

Ensure the creation, management, review, and quality approval of all aspects of required validation documentation such as master plans, project plans, URS, FRS (Functional Requirements Specification), impact assessments/risk assessments, revalidation plans, design documents, P&IDs, protocols/reports etc.
Ensure that facilities, laboratory equipment, utility systems and process equipment are maintained in qualified/validated state and that reports are written accurately and timely.
Maintain and manage departmental annual budget for internal and external resources and expenses for the Novato Site QA Validation Department.
Responsible for all QA Engineering activities for the Novato, CA Site.
Provide technical support in regulatory filings as required.
Collaborate with cross-functional teams to ensure quality considerations are integrated into product development and manufacturing processes.
Review and approve validation protocols and reports and Quality Management System