The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports shop floor activities for deviations, corrective and preventive actions (CAPAs), and aids in materials management for production operations.
Job DescriptionWhat You’ll Do
• Builds and manages the Manufacturing Support team
• Supervises the Manufacturing Support team and establish individual and team goals
• Oversees and coordinates team tasks, including managing the production scheduler
• Fosters an inclusive culture with development plans and regular meetings
• Coaches and supports team members for professional growth
• Acts as lead for regulatory inspections and audits
• Coordinates non-batch activities, own change controls, and manage Corrective Actions Preventative Actions within Trackwise
• Leads continuous improvement initiatives
• Manages batch record review and cycle time Key Performance Indicators
• 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.)
• Coaches and guides direct reports to foster professional development
• 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
Basic Requirements
• High School Diploma or GED with 11+ years of experience from a similar role in large pharma/biotech operations or projects OR
• Associate degree in Pharmaceutical Sciences, Life Sciences, or a related field with 9+ years of direct experience OR
• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, or related field with 7+ years of direct drug product manufacturing experience OR
• Equivalent military experience or training
• Up to 2 years of people management experience
• Experience working in a regulated GMP environment
Preferred Requirements
• 2-5 years of people management experience
• Experience in aseptic drug product manufacturing, cross-functional collaboration, sterile processing, or quality assurance
• Bioworks or BTEC Coursework
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to discern audible cuesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing colorAbility to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include wrists, hands and/or fingersAbility to conduct work that includes moving objects up to 10 pounds
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.
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