Center Director II | Octapharma

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 periods.
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.

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 meet targeted objectives.
Optimizes procurement efficiency through precise inventory management.
Ensures completion, approval, and timely submission of purchase orders in accordance with company accounting practices.

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, analyzes, and reports on training data within the Learning Management System, ensuring efficiency and compliance.
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.
Supports audit procedures by working with Center and Field Leadership to identify and address training needs for audit responses, deviations, and corrective/preventive actions.
Communicates ongoing training concerns and opportunities the Field Leadership team, ensuring alignment and proactive resolution of training-related issues within the centers.

Center Management

Center Director II is responsible for the management of a donor center designated as complex by Senior Management. Complexity is based on factors such as production volume, operating hours, staff size and complexity, physical location, donor base intricacy, market conditions, competition level, and product line complexity.
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.
Facilitates 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.

Additional Responsibility

Responsible for mentorship to those in Center Director I roles.
Serves as a subject matter expert and liaison to project management operations regarding strategic initiatives for the company.

Job Specifications:

B.S Degree preferred. Other combinations of education and experience may be considered.
3 years of operations and/or process management/supervisory experience required.
3-5 years of people management required, including recruiting, training, etc.
Experience in financial management and budgeting responsibilities required.
Experience working in a highly regulated industry preferred.
Ability to speak, read, write (legibly and accurately), and understand English required.
Strong communication, organizational skills required.
Excellent written, verbal, and interpersonal communication skills required.
Experience with office software preferred.
Ability to work daytime and evening hours, weekends, holidays, extended shifts and periodically after hours.

Physical Requirements:

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.
Ability to work in an environment with a temperature of -40C or colder for extended periods.
Occasional exposure to and handling of dry ice.
Ability to type and use basic computer skills.
Ability to use assistive devices if needed for mobility or communication.