Product Manufacturing Manager

Suncoast Communities Blood Bank•Bradenton, FL

About The Position

The Product Manufacturing Manager oversees the daily operations of the Product Manufacturing Department, ensuring that all component production, labeling, and distribution activities comply with regulatory standards and organizational SOPs. This position supervises staff, coordinates production scheduling, ensures product quality, and maintains adherence to FDA, AABB, and cGMP requirements. The Manager serves as a working leader who provides hands-on operational guidance, fosters staff development, and maintains a state of readiness for audits and inspections. This role partners closely with Quality Assurance, Laboratory, and Distribution to ensure safe, compliant, and efficient processing of lifesaving blood components that support SunCoast Blood Centers’ mission—to bring people together to save lives through innovative blood services and therapies. ESSENTIAL JOB FUNCTIONS Leadership and Supervision Serve as a working supervisor for the Product Manufacturing Department, ensuring all activities comply with SOPs and regulatory guidelines. Supervise, train, coach, and evaluate staff to maintain a high-functioning, compliant team. Prepare and manage departmental work schedules and ensure proper coverage. Interview and recommend qualified candidates for Product Manufacturing positions. Administer the automated time and attendance system for departmental staff. Support the development and implementation of annual competency plans; assist with corrective actions as needed. Participate in investigations and assist in resolving internal staff concerns. Assume full management responsibilities for the Product Manufacturing Department in the absence of the co-manager. Compliance and Quality Assurance Ensure staff adherence to all applicable regulatory, quality, and safety standards. Manage error-handling processes, including documentation, investigation, and corrective action plans for non-compliance or operational issues. Conduct internal audits, ensure timely corrective actions, and maintain audit readiness. Maintain and organize training files, documentation, and departmental records for inspection accessibility. Oversee the development, review, and maintenance of department SOPs. Participate in process improvement projects that enhance safety, compliance, and efficiency. Operational Management Oversee day-to-day component manufacturing, labeling, and storage activities to ensure quality, efficiency, and compliance with cGMP standards. Ensure accurate completion of production and test result documentation. Manage the timely transfer of test results to ensure correct product labeling and disposition. Resolve all incomplete or unfinalized test results daily. Prepare and submit donor deferral notifications to Quality Assurance. Ensure accurate inventory control of blood components and related materials. Anticipate hospital and product needs based on inventory reports and coordinate accordingly. Assist with preparation and scheduling of periodic maintenance, calibration, and validation of instruments and equipment. Write and execute validations prior to implementing new processes, equipment, or software. Training and Competency Oversee ongoing training programs for staff related to new and updated processes. Ensure annual competency plans are executed and documented for all employees. Provide retraining as necessary for performance improvement or regulatory updates. Ensure training files, certifications, and competency assessments are maintained in compliance with policy. Quality Control and Product Release Determine and monitor required sample size for monthly Quality Control (QC) testing. Assist with the development, performance, and scheduling of product QC activities. Ensure timely product review and release following completion of testing. Oversee the resolution of any discrepancies or product holds related to QC. Collaborate with QA and laboratory teams to ensure integrity of product data and labeling accuracy. Professional and Organizational Support Participate in continuing professional development activities. Collaborate with other departments to maintain smooth workflow and shared operational goals. Maintain confidentiality and security of donor and product information. Perform other duties as required to support SunCoast Blood Centers’ mission, vision, and values.

Requirements

Bachelor’s degree in Medical Technology, Biology, or related field preferred. Equivalent experience in blood banking or component manufacturing may be considered.
Minimum of five years of experience in blood banking, component manufacturing, or laboratory operations, with at least two years in a leadership or supervisory role.
In-depth understanding of FDA, AABB, cGMP, and related regulatory requirements.
Strong analytical and problem-solving skills.
Ability to train, mentor, and develop technical staff.
Excellent written and verbal communication skills.
Demonstrated ability to manage multiple priorities in a regulated environment.
Competence in automated systems and laboratory information management systems (LIMS).
High attention to detail and commitment to quality.
Valid Florida Driver’s License and reliable transportation.

Nice To Haves

Florida Clinical Laboratory License preferred.

Responsibilities

Serve as a working supervisor for the Product Manufacturing Department, ensuring all activities comply with SOPs and regulatory guidelines.
Supervise, train, coach, and evaluate staff to maintain a high-functioning, compliant team.
Prepare and manage departmental work schedules and ensure proper coverage.
Interview and recommend qualified candidates for Product Manufacturing positions.
Administer the automated time and attendance system for departmental staff.
Support the development and implementation of annual competency plans; assist with corrective actions as needed.
Participate in investigations and assist in resolving internal staff concerns.
Assume full management responsibilities for the Product Manufacturing Department in the absence of the co-manager.
Ensure staff adherence to all applicable regulatory, quality, and safety standards.
Manage error-handling processes, including documentation, investigation, and corrective action plans for non-compliance or operational issues.
Conduct internal audits, ensure timely corrective actions, and maintain audit readiness.
Maintain and organize training files, documentation, and departmental records for inspection accessibility.
Oversee the development, review, and maintenance of department SOPs.
Participate in process improvement projects that enhance safety, compliance, and efficiency.
Oversee day-to-day component manufacturing, labeling, and storage activities to ensure quality, efficiency, and compliance with cGMP standards.
Ensure accurate completion of production and test result documentation.
Manage the timely transfer of test results to ensure correct product labeling and disposition.
Resolve all incomplete or unfinalized test results daily.
Prepare and submit donor deferral notifications to Quality Assurance.
Ensure accurate inventory control of blood components and related materials.
Anticipate hospital and product needs based on inventory reports and coordinate accordingly.
Assist with preparation and scheduling of periodic maintenance, calibration, and validation of instruments and equipment.
Write and execute validations prior to implementing new processes, equipment, or software.
Oversee ongoing training programs for staff related to new and updated processes.
Ensure annual competency plans are executed and documented for all employees.
Provide retraining as necessary for performance improvement or regulatory updates.
Ensure training files, certifications, and competency assessments are maintained in compliance with policy.
Determine and monitor required sample size for monthly Quality Control (QC) testing.
Assist with the development, performance, and scheduling of product QC activities.
Ensure timely product review and release following completion of testing.
Oversee the resolution of any discrepancies or product holds related to QC.
Collaborate with QA and laboratory teams to ensure integrity of product data and labeling accuracy.
Participate in continuing professional development activities.
Collaborate with other departments to maintain smooth workflow and shared operational goals.
Maintain confidentiality and security of donor and product information.
Perform other duties as required to support SunCoast Blood Centers’ mission, vision, and values.