Manager, All QC

Fujifilm•Holly Springs, NC

About The Position

The Manager, All-QC team is responsible for contributing to key functional, tactical, and operational aspects of the QC group and will lead the 223-shift teams that are responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all the QC laboratories required for urgent testing/Manufacturing support. This role will direct the scheduling across all shifts, initiation of process improvements, serve as a liaison across all QC teams, modeling the leadership competencies, aiding in the development of peers and performing QC approvals, as required.

Requirements

Bachelor’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 4+ years of related experience OR
Master’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 2+ years of related experience
Degree with emphasis in life science or engineering preferred
4+ years’ experience managing people
Experience working in a changing, project driven organization
Previous experience directly supporting function
Experience with regulatory inspections, investigations and change management preferred
Experience in pharmaceutical / biological manufacturing operations preferred
Experience leading others in a pharmaceutical/biological manufacturing facility preferred

Nice To Haves

5+ years of experience in a GMP environment

Responsibilities

Ensures and owns GMP-compliant laboratory operations in alignment with EU GMP, 21 CFR Parts 210, 211, 820, 11, and other applicable GMP guidelines.
Provides cross-functional leadership and mentorship as the QC laboratory representative.
Directs four shift supervisors to ensure 24/7 QC team coverage.
Oversees supervision and scheduling across 223 shifts for the All-QC laboratory team.
Applies expertise in laboratory methodology and compendial requirements for QC testing that span all the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
Acts as primary point of contact for their team and first line escalation point in areas of their responsibility.
Coordinates the review of analytical data to support test validation, qualification and certification activities. Performs investigations, manages complex issues, barriers and problems to support team success. Approve data reports within the team and area of discipline/focus, including approval of results
Authors protocols, change control requests, and Quality Technical Reports for ensuring successful execution of, qualification, analytical improvement projects, in collaboration with cross-functional teams, as appropriate
Provides technical leadership through effective project management, status tracking, presentations, and communication
Proactively identifies technical gaps and areas for improvement related to quality. Process and lead internal and external audits proficiently, including commitments on follow up within team & site management, serves as External Leadership cross-functionally.
Represents QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders
Provides regular guidance to direct reports; fosters a positive, collaborative work environment that prioritizes team success; mentors junior staff in quality systems and continuous process improvement.
Establishes clear requirements, deliverables, measurable goals and targets, and mitigation plans aligned with quality directives, regulatory guidance, and business priorities.
Ensures timely and appropriate mitigation of issues and deviations.
Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management. Supports key business strategies
Conducts approval of complex reports, data of others; Leads complex problem solving through facilitation/escalation. Conducts impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations).
Provides technical support during audits/inspections
Ensures adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers
Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
Performs other duties, as assigned