Manager, All QC

Position Overview 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, and environmental monitoring. This role is part of a 24x7 team that supports testing and sampling across all QC laboratories required for urgent testing and manufacturing support. The Manager will direct scheduling across all shifts, initiate process improvements, serve as a liaison across all QC teams, model leadership competencies, aid in the development of peers, and perform QC approvals as required. Job Description What You'll Do Ensure and own GMP-compliant laboratory operations in alignment with EU GMP, 21 CFR Parts 210, 211, 820, 11, and other applicable GMP guidelines. Provide cross-functional leadership and mentorship as the QC laboratory representative. Direct four shift supervisors to ensure 24/7 QC team coverage. Oversee supervision and scheduling across 223 shifts for the All-QC laboratory team. Apply 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 and test methods for samples associated with manufactured batches. Act as primary point of contact for the team and first line escalation point in areas of responsibility. Coordinate the review of analytical data to support test validation, qualification and certification activities; perform investigations, manage complex issues, barriers and problems to support team success; approve data reports within the team and area of discipline/focus, including approval of results. Author protocols, change control requests, and Quality Technical Reports to ensure successful execution of qualification, analytical improvement projects in collaboration with cross-functional teams. Provide technical leadership through effective project management, status tracking, presentations, and communication. Proactively identify technical gaps and improvement areas related to quality; process and lead internal and external audits proficiently, including commitments on follow up within team & site management, and serve as external leadership cross-functionally. Represent QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders. Provide regular guidance to direct reports; foster a positive, collaborative work environment that prioritizes team success; mentor junior staff in quality systems and continuous process improvement. Establish clear requirements, deliverables, measurable goals and targets, and mitigation plans aligned with quality directives, regulatory guidance, and business priorities. Ensure timely and appropriate mitigation of issues and deviations. Manage complex problem solving, providing mitigation/outcome to management and team; decisions at this level may have potential compliance impact to methods, results, product, and/or quality systems, with impact to customers or personnel issues that must be handled with consultation and recommendations to management; support key business strategies. Conduct approval of complex reports and data of others; lead complex problem solving through facilitation and escalation; conduct impact assessment related to compliance. Provide technical support during audits and inspections. Ensure adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers. Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports). Participate in recruitment process and retention strategies to attract and retain talent as needed. Address performance gaps, employee questions and concerns, and partner with HR as needed for resolution. Perform other duties as assigned. Minimum Requirements Bachelor's degree in chemistry, microbiology, biological sciences, engineering or related science with 4+ years of related experience. 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 of 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 or biological manufacturing operations preferred. Experience leading others in a pharmaceutical or 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 wrist, hand, 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. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr Merck & Co.