NCBiotech
Manager, Compliance & Support, Drug Product
NCBiotech, Holly Springs, North Carolina, United States, 27540
Manager, Compliance & Support, Drug Product
Position Overview
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 Description What 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 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
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
Ability to conduct work that includes moving objects up to 10 pounds
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Job Description What 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 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
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
Ability to conduct work that includes moving objects up to 10 pounds
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