Director, Head of the Product Quality Controls & Performance Systems (CPS)

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.

Director, Head of the Product Quality Controls & Performance Systems (CPS)

Summary Description
BioMarin is seeking a Director to lead the Product Quality Controls & Performance Systems (CPS) team.  Reporting to the Head of Product Quality Lifecycle Management, this individual will be responsible to develop a high-performing team driving the continuing development and implementation of key systems and controls that define, maintain, and identify opportunities to improve product quality.  These systems and controls include (1) product stability strategy design and execution, (2) Annual Product Review of manufacturing, process controls and quality data, and (3) the product specification document lifecycle process.  Cross functional collaboration with partners and stakeholders across different functions and global sites is key for success in this role.  The Director will foster a culture of continuous improvement, providing strategic direction for areas of responsibility and setting clear expectations, goals, and metrics for the team. The products supported by the team span different platforms (e.g., biologics, devices, gene therapies, oligonucleotides, and small molecules), encompass various stages of product lifecycle (early/late stage clinical, commercial programs), and have activities spanning global production nodes, clinical sites, and commercial markets.  This position thus requires a broad range of knowledge and experience with biologic/synthetic manufacturing processes, drug development stages, analytical testing methods, and understanding of the international regulatory landscape. Responsibilities
•    Lead a team of stability SME’s responsible for devising strategic input to the design, implementation and harmonization of stability programs following ICH guidelines and country-specific requirements.
•    Develop and maintain team capability to drive stakeholder collaboration for incorporation of program SME input on design, planning and execution of stability program.  
•    Provide leadership for development of an integrated electronic stability program management system to provide overview of global stability programs by product, site, and lifecycle phase, including real-time information on time point status and laboratory testing resource requirements.
•    Ensure capability of team to provide statistical analyses guidance/expertise for provision of shelf-life projections, support of proposals for end-of-shelf-life product specifications, monitoring of performance of stability batches and meeting regulatory reporting requirements, using statistical analysis software (e.g., JMP).
•    Provide strategic input for content authoring and support review of stability-related content for INDs/IMPDs, BLAs/MAAs and health agency information requests.
•    Develop and implement stability monitoring plans and data trending processes for all cell, plasmid, and bacmid banks used for GMP manufacturing. 
•    Lead team owning and coordinating the Annual Product Review process for assembling and assessing the manufacturing, process control and quality data to evaluate licensed commercial products. 
•    Drive the transformation of the current APR and product specification document processes to further standardize and streamline inputs/outputs, reduce cycle times, prevent back log and drive to planned, predictable performance. 
•    Partner with cross-functional stakeholders to identify scope and efficient implementation of single-site and E2E elements of Annual Product Reviews.
•    Further develop the Annual Product Review business process to strengthen data-driven decision making for identification of process/analytical/control strategy improvements projects as part of the Technical Product Agenda creation.  
•    Lead the specification management team owning the product specification document lifecycle process (creation, revision, approval).
•    Develop/improve standard implementation plans for change control activities required to create/maintain product specification documents, including standardized assessments, change plans and reviewers/approvers.
•    Provide direction and expert knowledge in the day-to-day strategic functions of global stability, product specification document-related processes and annual product review.
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