Center Director III
JOB TITLE: Associate Center Director III
CLASSIFICATION: Exempt
DEPARTMENT: Donor Center
REPORTS TO: Regional Director
MANAGERIALLY RESPONSIBLE FOR: Associate Center Director 
POSITION PURPOSE: Center Director III assists the Regional Director with management and supervision of donation centers within their region, ensuring unwavering compliance with SOP, cGMP, and regulatory guidelines. They skillfully navigate the orchestration of staff, operations, and financial matters while seamlessly serving as a crucial liaison with Field Leadership and corporate functions.
Essential Job Functions:

Compliance 

  • Maintains a thorough understanding of and ensures total operation is compliant with state and federal regulations (e.g., FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance.
  • Hosts internal and external audits conducted by regulatory agencies and customers.
  • Participates in and reinforces the support for quality improvement initiatives to enhance operational efficiency and product quality. Identify opportunities for process optimization and contributes to the development of best practices.
  • Collaborates with relevant departments to implement corrective and preventive actions (CAPA) to address identified issues.
  • Ensures all certifications, including state specific licenses/certifications, are maintained, tracked, and recorded within required time frames.
  • Promotes Safety, Health, and Environment Policies & Procedures. Ensure safety training and safety practices are implemented and followed within the center.
  • Responsible for mitigating and resolving safety concerns.
  • Oversees the performance of preventive maintenance of donor center equipment to ensure that the equipment is well-maintained and in good working order.
  • Ensures the facility is always well-maintained, clean, and neat.

Risk Management
  • Maintains all donor center functions and assets.
  • Keeps immediate supervisor informed of any irregularities within the center.
  • Mitigates and reports all unsafe situations and conditions.
  • Responsible for regular meetings with Regional Director in identifying, reviewing, and establishing action plans to eliminate risk associated with quality, training, and safety non-compliance.
  • Reviews, approves, and ensures effective implementation and resolution of CAPAs. Assists Donor Center Management in developing and monitoring all corrective actions to prevent recurrence and conducts performance checks to ensure effectiveness of corrective and preventive actions.

Product Inventory Management
  • Responsible for product inventory and ensures compliance with Standard Operating Procedures.
  • Partners with applicable corporate departments and vendors to maximize efficiency and product shipments.
  • Responsible for integrity of product and sample storage equipment, including mitigation of equipment failure and maintenance.
  • Manages unsuitable product per Standard Operating Procedures.

Budget and Fiscal Control
  • Responsible for achieving targeted production in quantity and quality.
  • Optimizes operational cost to meeting and exceeding targeted objectives.
  • Optimizes procurement efficiency through precise inventory management.
  • Ensures completion, approval, and timely submission of purchase orders in accordance with company accounting practices.
  • Reviews business KPIs and addresses metrics that are not meeting targets. Responsible for utilizing appropriate remote tools to review and assess the operations of donor center(s) in the region under the direction of the Regional Director.

Employee Relations
  • Conducts comprehensive employee performance evaluations, performance improvement plans, individual development plans and corrective actions as applicable.
  • Steers impactful employment decisions encompassing strategic hiring, promotions, demotions, and terminations ensuring alignment for employee aspirations and advancing the strategic goals of the business.
  • Creates robust and positive culture within the donor center, exemplifying core values.
  • Ensures adherence to all HR policies and procedures including workers compensation, talent acquisition, compensation, benefits, leave of absence, ADA/accommodations, employee relations.
  • Assists in employee relations investigations.
  • Mentors staff for thorough adherence to safety, quality policies, and regulatory requirements.

Training and Development
  • Facilitates and administers center level employee training ensuring alignment with compliance standards, while overseeing their execution and timeliness.
  • Responsible for Donor Center leadership training
  • Supervises the implementation of training procedures, encompassing both the induction of new processes and the annual retraining initiatives.
  • Tracks and analyzes training data within the Learning Management System, ensuring timely completion of initial and annual training modules tailored to specific roles and individual staff members.
  • Manages the onboarding process for new hires, collaborating closely with designated Trainers to schedule and ensure follow-ups.
  • Maintains training documentation and conducts routine audits to uphold legal, regulatory, and company-mandated standards, guaranteeing comprehensive compliance in all training records.
  • Manages the tracking, maintenance, and recording of all certifications, including state-specific licenses, ensuring strict adherence to mandated timeframes and requirements.
  • Offers insights into training requirements connected with deviations and collaborates with the Quality department to develop tailored training interventions aimed at resolving identified issues effectively.
  • Assists in the audit procedures by collaborating closely with the Center Leadership team, Field Quality, and Field Leadership team to identify and address training needs essential for major audit responses, deviations, and the implementation of corrective and preventive actions.
  • Communicates ongoing training concerns and opportunities the Field Training team, ensuring alignment and proactive resolution of training-related issues within the centers.

Center Management
  • Center Director III manages and oversees their “home” donor center. In addition, under the direction of the Regional Director, assists with oversight of other donation centers within their Region.
  • Under the direction of the Regional Director, conducts visits to each donor center in assigned region and periodically attends and/or leads donor center monthly staff meetings.
  • Cultivates a positive and respectful rapport with donors, fostering retention, referrals, and growth.
  • Manges and oversees Payroll records to optimize the efficient allocation of employee hours.
  • Facilitate routine staff and leadership meetings.
  • Strategically manages operational Key Performance Indicators (KPIs), taking a proactive approach to identify and rectify any operational deficiencies for optimized performance.
  • Oversees marketing and advertising initiatives, collaborating with relevant corporate departments to pinpoint and implement essential enhancements.
  • Ensures representation of the Company in various communities and with other businesses, publications, vendors, and regulatory agencies.

Additional Responsibility
  • Serves as a subject matter expert and liaison to project management operations regarding strategic initiatives for the company.
  • Serves as a subject matter expert and liaison to change control board.

Job Specifications:
  • B.S. or B.A. degree preferred. Other combinations of education and experience may be considered.
  • Relocation flexibility is preferred.
  • 3-5 years’ job-related experience in biologics, drug manufacturing, medical device or FDA regulated laboratory facility, including a minimum of one (1) year related experience in a plasma donor center, is preferred.
  • Experience with responsibility for financial management and/or budgeting preferred.
  • Experience working in a highly regulated industry preferred.
  • Strong communication, organizational skills required.
  • Excellent written, verbal, and interpersonal communication skills required.
  • Experience with Microsoft Office required.
  • Ability to work daytime and evening hours, weekends, holidays, extended shifts and periodically after hours.

Physical Requirements:
  • Travel up to 50% of time to include overnight travel and may include weekends.
  • Ability to sit or stand for extended periods for up to four (4) hours at a time.
  • Ability to tug, lift, and pull up to thirty-five (35) pounds.
  • Ability to bend, stoop or kneel.
  • Occupational exposure to blood borne pathogens.
  • Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time.
  • The employee is required to enter an environment with a temperature of -40C for short periods of time.
  • Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time.
  • Ability to type and use basic computer skills.