Position OverviewThe 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.
Job DescriptionWhat You'll Do- 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
Minimum 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
Preferred Requirements:- 5+ years of experience in a GMP environment
Physical and Work Environment Requirements:- Ability to discern audible cues
- Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
- Ability to stand for prolonged periods of time (up to 240 minutes)
- Ability to sit for prolonged periods of time (up to 240 minutes)
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
- Ability to conduct work that includes moving objects up to 33 pounds.
- Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
