Associate Manager, QC Raw Materials

Fujifilm•Holly Springs, NC

4d•Onsite

About The Position

The Associate Manager leads a subsection of the Global QC Raw Material group, ensuring that day-to-day tasks are carried out efficiently in relation to raw material activities for tech transfers and material lifecycle management. This involves coordinating the team’s workload, developing team members through targeted training and performance evaluations, and driving projects and cross-site collaboration. The function also includes tracking team progress, promoting innovation, and ensuring alignment with departmental milestones, as well as global QC milestones. Through effective communication, resource management, and strategic oversight, the Associate Manager fosters overall quality, compliance, and continuous improvement within the organization.

Requirements

Bachelor’s degree in Life Sciences or Engineering and 6+ years of experience in GMP quality assurance and/or similar role OR, Master’s degree in Life Sciences or Engineering and 4+ years of experience in GMP quality assurance and/or similar role.
5+ years of experience within pharmaceutical industry, preferably within the field of starting materials.
Prior leadership experience.
Advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH)
Broad knowledge of quality control operations, systems, and directives.
Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
Excellent leadership and people management skills.
Excellent technical writing skills, and clear oral and written presentation abilities.
Ability to make clear and informed decisions with limited information based on previous experience with analytical transfers.
Strong stakeholder management and communication skills, enabling alignment across sites and global functions.
Strong organizational skills with an ability to multi-task and coordinate multiple activities in parallel.
Able to work effectively, independently and within a team framework, across all business areas and levels of the organization.
Ability to coach, lead, and develop individual contributors.

Nice To Haves

2+ years of direct supervisory experience.
5+ years of experience in a GMP environment.
Experience with Microsoft Office, Smartsheet, LIMS and ERP systems (e.g., SAP).

Responsibilities

Coordinates day-to-day activities, scheduling and resource allocation, balancing the QC Raw materials team’s workload against established priorities and management milestones (e.g., report/data approval, schedules, quality systems).
Implements best industry practices, identifies areas for improvement, and continuously seeks to enhance operational quality and efficiency in close collaboration with the remainder of the Global QC Raw Material leadership team.
Authors and reviews procedures, documents, and reports to support QC Raw Materials operations and tech transfer activities; routes for approval per quality systems.
Maintains GMP-compliant operations by adhering to procedures, global directives, and quality systems; ensures inspection readiness and complete, accurate documentation.
Represents the team both within and outside the organization, facilitating clear communication and fostering collaborative relationships.
Optimizes team performance by systematically tracking workload, successes, and challenges, and by recommending improvements to support overall departmental efficiency.
Supports tech transfer projects by coordinating materials readiness, data collection, and actively engaging in customer communications.
Collaborates cross-functionally with QC Analytical Development, QC Program Management, Manufacturing, Process Science, Supply chain and Quality Assurance to meet program deliverables.
Execute first-line people leadership tasks per company policies, including on-the-job coaching, feedback, and day-to-day guidance of team members.
Administers company policies such as time off, shift work, and inclement weather that directly impact employees.
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).
Performs other duties as assigned.