Senior Manager, MSAT

PCI Pharma Services•San Diego, CA

3d•$133,920 - $150,660

About The Position

The Senior Manager, Technical Documentation provides strategic, technical, and operational leadership for the Manufacturing Science & Technology (MSAT) documentation function. The role ensures consistent application of cGMP requirements and documentation standards across technology transfers, new product introductions, process changes, and commercial manufacturing operations. It establishes and governs site- and segment-level documentation strategies, systems, and processes for compliant, efficient, and scalable clinical and commercial manufacturing. The position leads development, oversight, and continuous improvement of Master Batch Records (MBRs), manufacturing procedures, technical reports, specifications, and other controlled documentation. As the technical authority for MSAT documentation, the Senior Manager drives standardization, best practices, and governance across sites, ensuring documentation supports technology transfer, process validation, manufacturing readiness, operational excellence, and regulatory compliance. The role leads complex cross-functional initiatives in partnership with MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory, and Project Management teams. It establishes documentation governance, monitors performance metrics and quality trends, assesses compliance risks, and drives improvements that enhance product quality, inspection readiness, and operational efficiency. The Senior Manager also advises site and segment leadership on long-term strategies, organizational capabilities, and documentation processes aligned with business objectives, regulatory expectations, and growth plans.

Requirements

Bachelor’s degree in a Life Sciences discipline or equivalent experience.
Minimum of seven years of experience in aseptic manufacturing environments, microbiology, or quality assurance.
Minimum of three or more years of leadership or supervisory experience.
Expert-level knowledge of global pharmaceutical cGMPs.
Expert understanding of equipment, systems, and technologies, including how to translate issues into accurate documentation.
Ability to lead the development of solutions to complex problems requiring ingenuity, creativity, and innovation.
Detail-oriented with expert written and verbal communication skills.
Ability to work autonomously within prescribed guidelines or as a team member.
Ability to lead and develop employees and foster an environment that encourages development.
High proficiency in Microsoft Office applications.

Responsibilities

Establish and govern site- and segment-wide MSAT documentation strategies, standards, and processes for technology transfer, NPI, process validation, commercial manufacturing, and regulatory compliance.
Provide strategic, technical, and operational leadership for the Technical Documentation function and promote consistent cGMP application and documentation best practices.
Lead development, review, approval, implementation, and lifecycle management of Master Batch Records, manufacturing procedures, specifications, technical reports, and other controlled GMP documentation.
Serve as the segment subject matter expert and technical authority for manufacturing documentation, advising cross-functional 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 for documentation quality, compliance, execution efficiency, and inspection readiness.
Lead cross-functional initiatives to resolve technical, operational, and compliance challenges affecting manufacturing performance, product quality, and regulatory requirements.
Oversee documentation-related quality events, change controls, CAPAs, deviations, and technical investigations, ensuring timely resolution, effectiveness verification, and continuous improvement.
Monitor and trend documentation, process, and compliance metrics to identify systemic issues, assess risk, and implement sustainable corrective and preventive actions.
Drive standardization, harmonization, and continuous improvement of documentation systems, templates, workflows, and governance practices across the network.
Partner with site and segment leadership on long-range strategies, organizational capabilities, and operating models supporting growth, technical excellence, and scalability.
Provide leadership and oversight for departmental objectives, resource planning, project prioritization, and execution in alignment with corporate goals and customer commitments.
Support internal audits, client audits, and regulatory inspections by maintaining compliant, inspection-ready documentation systems.
Mentor, develop, and lead Technical Documentation personnel, fostering accountability, continuous improvement, technical rigor, and operational excellence.
Represent the organization in client interactions, governance forums, technical reviews, and executive discussions related to transfers, manufacturing readiness, compliance strategy, and process improvement.
Build collaborative relationships with internal stakeholders and external partners to support technical and business objectives.
Ensure compliance with PCI policies, cGMP regulations, quality standards, and EHS requirements.
Set performance standards and encourage employee engagement and results through delegation, feedback, goal setting, and performance management.
Maintain transparent communication through department and one-on-one meetings, email, and regular interpersonal communication.
Provide oversight and direction to employees in accordance with PCI Pharma Services policies and procedures.