Senior Technical Manager, Novato Quality Compliance
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 self-inspection program for all GMP areas including clinical manufacturing and testing areas including network services that are managed out of the Novato site.
This position will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Novato and to build inspection readiness capability across the organization. This role will help to build mechanisms within the business to educate on compliance awareness and ensure we are performing in compliance. The Sr. Technical Manager will also provide support during regulatory inspections.
This position requires critical thinking, high level of influencing, collaboration, leadership courage as well as a broad range of knowledge and experience with biologic and chemical processes, in-depth knowledge of GMP compliance across various drug manufacturing stages, self-inspection principles as well as managing and interacting with health authorities during inspections.
KEY RESPONSIBILITIES
-Establish and maintain an effective self-inspection program for the Novato site that is inclusive of all GMP activities to continuously increase our GMP compliance state and facilitate constant inspection readiness. Effectively collaborate with Novato Leadership Team (NLT) to obtain endorsement and sponsorship of the program.
-Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
-Effectively collaborate with Global GMP audit team
-Establish and maintain community of practice with other BioMarin Sites to benchmark, improve and standardize (as needed) across the network.
-Define and implement systems, and metrics for maintaining regulatory compliance for all operations.
-Perform evaluations of GMP compliance across all site areas and procedures and processes.
-Benchmark leading practices within our peers in the industry and implement improvements.
-Identify trends in recent regulatory inspections and translate this to the self-inspection program to improve readiness.
-Work closely with the compliance team to close gaps and improve inspection readiness capabilities.
-Responsible for Novato Site GMP training program, training material content generation and requirements.
-Knowledgeable in current industry compliance and inspection trends.
-Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.
Experience:
-10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or Other highly regulated industry
-5+ years experience with leading/hosting regulatory inspections, managing inspection readiness programs, self-audit programs and inspection response process required. Experience in Quality, Compliance and MSAT preferred.
-Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
-Demonstrated ability to partner with other functional groups to achieve business objectives.
-Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.
-Excellent organizational agility that demonstrates how to get results while strengthening internal and
external relationships with minimal resources.
-Consistent demonstration of leadership courage
-Ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally.
-Results oriented; effectively manages multiple projects efficiently.
-Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker.
-In-depth understanding and application of cGMP principles, concepts, practices, and standards
-Regulatory, Quality, Compliance, or a combination of technical experience such as analytical development/manufacturing sciences and Quality/Regulatory.
-Proficiency in data analysis and visual management tools
Education:
-BA/BS in life sciences or related field
-Advance degree desirable, but not required.
Other:
-This role requires being on site and 5 days/week.
-Ability to travel domestically and internationally up to 30%
