Senior Technical Manager, Novato Quality Compliance (MQR)
SUMMARY
The Senior Technical Manager is part of the Novato Quality Compliance group reporting to the Head of Compliance. The role is responsible and accountable for establishing and maintaining Novato’s Manufacturing Quality Management System Review as well as establishing and executing site Annual Product Review (APR) programs.
This position will be responsible for establishing Manufacturing Quality Review (MQR) process and system that assesses Novato manufacturing quality management system performance, effectiveness and adequacy and identify opportunities for improvement. The Senior Technical Manager is also responsible for establishing and maintaining Annual Product Reviews (APRs) for all products manufactured at the Novato Site (PPQ to commercial). The MQR and APRs together provide critical information on the performance and effectiveness of our QMS and Products health.
This role requires close cross-functional collaborations to drive activities that will ensure a state of continuous GMP compliance in Novato and identify for opportunities for improvements. This position requires critical thinking ability, high level of influencing, collaboration, leadership courage as well as a broad range of knowledge and experience with biologic and chemical processes, and in-depth knowledge of GMP compliance across various drug manufacturing stages.
KEY RESPONSIBILITIES
-Establish Novato site specific APR process and procedures.
-Ensure Novato APR is executed according to procedures.
-Author Novato site APR. Collaborate with stakeholders to identify, escalate, and resolve issues.
-Establish and maintain Novato’s MQR process and systems.
-Effectively collaborate with Global Quality Assurance ensuring alignment with QSMR process and expectations
-Effectively collaborate with Product Quality Life Cycle Management group in establishing Novato APR Process ensuring alignment.
-Establish and maintain community of practice with other BioMarin Sites to benchmark, improve and standardize (as needed) across the network.
-Interact with senior level leadership teams in Novato and across the network to escalate significant issues or obtain sponsorship of initiatives for MQR and APR processes.
-Define and implement systems, and metrics.
-Benchmark leading practices within our peers in the industry and implement improvements.
-Work closely with the compliance team to close gaps and improve inspection readiness capabilities.
-Provide training on APR and MQR as needed.
-Support regulatory inspections.
Experience:
-10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
-7+ years experience in quality/compliance, MSAT or other technical areas.
-Demonstrated strong knowledge of Global pharmaceutical/biotechnology industry regulations, and GMPs as well as BioMarin’s and guidance documents. Ability to interpret standards for implementation and review requited.
-Strong Knowledge of analytical and manufacturing data required.
-Demonstrated knowledge, application and use of statistics, data acquisitions, visual management tools, and other technology platforms.
-Excellent interpersonal and communication skills (written & verbal) and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally and at all levels.
-Demonstrated ability to partner with other functional group to achieve business objectives.
-Demonstrated ability to work effectively in a matrix environment and drive results through influencing to resolve complex technical, quality, and business-related issues.
-Demonstrated ability to drive continuous improvement and operating with a Lean and Agile mindset.
-Consistent demonstration of leadership courage
-Results oriented; effectively manages multiple projects efficiently.
-In-depth understanding and application of cGMP principles, concepts, practices, and standards
Education:
-This role requires being on site and 5 days/week.
-Ability to travel domestically and internationally up to 30%
Other:
Ability to travel up to 30%
