Senior Manager, MSAT

PCI Pharma Services•San Diego, CA

About The Position

The Senior Manager 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 site- and segment-level documentation strategies, systems, and processes that support 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 and governance across sites and ensures 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. As an advisor to site and segment leadership, the Senior Manager develops strategies, organizational capabilities, and processes aligned with business objectives, regulatory expectations, and growth plans. The position also leads and develops Technical Documentation personnel and promotes technical excellence, compliance, and continuous improvement.

Requirements

Bachelor’s degree in a life sciences discipline or equivalent experience.
At least 7 years of experience in aseptic manufacturing environments, microbiology, or quality assurance.
At least 3 years of leadership or supervisory experience.
Expert-level knowledge of global pharmaceutical cGMPs.
Expert understanding of equipment, systems, and technologies, and the ability 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 and as a team member.
Ability to lead and develop employees and foster an environment that encourages their development.
High proficiency with Microsoft Office applications.

Responsibilities

Establish and govern site- and segment-wide MSAT documentation strategies, standards, and processes supporting technology transfer, new product introduction, 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 across sites.
Lead cross-functional initiatives to address 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, including timely resolution and effectiveness verification.
Monitor and trend documentation, process, and compliance metrics; identify systemic issues and risks; 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 that support business growth and operational scalability.
Lead 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 and inspection-ready documentation systems.
Mentor, develop, and lead Technical Documentation personnel, fostering accountability, technical rigor, continuous improvement, and operational excellence.
Represent the organization in client interactions, governance forums, technical reviews, and executive discussions concerning transfers, manufacturing readiness, compliance strategy, and process improvement.
Develop collaborative relationships with internal stakeholders and external partners to support technical and business objectives.
Ensure compliance with PCI policies, cGMP regulations, quality standards, and Environmental Health and Safety requirements.
Set performance standards and support employee engagement and results through delegation, continuous 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.