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Summary:
The Senior Manager, Technical Documentation provides strategic, technical, and operational leadership for the Manufacturing Science & Technology (MSAT) documentation function, ensuring the consistent application of cGMP requirements and documentation standards across technology transfers, new product introductions (NPI), process changes, and commercial manufacturing operations. The role establishes and governs site and segment-level documentation strategies, systems, and processes that support compliant, efficient, and scalable clinical and commercial manufacturing.
This position leads the development, oversight, and continuous improvement of Master Batch Records (MBRs), manufacturing procedures, technical reports, specifications, and associated controlled documentation. The Senior Manager serves as the technical authority for MSAT documentation, driving standardization, best practices, and governance across sites while ensuring documentation effectively supports technology transfer, process validation, manufacturing readiness, operational excellence, and regulatory compliance.
The role provides leadership for complex cross-functional initiatives, partnering closely with MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory, and Project Management teams to resolve technical issues, implement process improvements, and ensure successful execution of new and existing clinical and commercial programs. The position is responsible for establishing documentation governance, monitoring performance metrics and quality trends, assessing compliance risks, and driving continuous improvement initiatives that enhance product quality, inspection readiness, and operational efficiency.
As a key advisor to site and segment leadership, the Senior Manager develops long-term strategies, organizational capabilities, and documentation processes that align with business objectives, regulatory expectations, and growth plans. The position fosters a culture of technical excellence, compliance, and continuous improvement while enabling successful technology transfer, accelerated product introduction, and sustainable manufacturing performance across the network.
Essential Duties and Responsibilities:
Establish and govern site and segment-wide MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.
Provide strategic, technical, and operational leadership for the Technical Documentation function, ensuring consistent application of cGMP requirements and documentation best practices across the organization.
Lead the development, review, approval, implementation, and lifecycle management of Master Batch Records (MBRs), manufacturing procedures, specifications, technical reports, and other controlled GMP documentation.
Serve as the segment subject matter expert and technical authority for manufacturing documentation, providing guidance to MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, and Project Management teams.
Direct documentation activities supporting technology transfers, process scale-up, process validation, new product introductions, and commercial manufacturing readiness
Establish governance processes and performance metrics to ensure documentation quality, compliance, execution efficiency, and inspection readiness across all sites.
Lead complex cross-functional initiatives to resolve technical, operational, and compliance challenges that impact manufacturing performance, product quality, and regulatory requirements.
Oversee documentation-related quality events,…