ImmunoTek Bio Centers is currently looking for a Regional Director of Operations!!!!
ImmunoTek is seeking professionals with a passion for saving lives and professional development. ImmunoTek is not just a place to get a job; it's a place to forge a career. We are governed by a set of core principles that guide us through all facets of our business. These principles set the tone for the method in which we hire, train, develop and collaborate with our most important asset...our people.
People are the most important part of our company. We are passionate about three groups of people:
We value the amazing employees ImmunoTek Associates who have made the decision to join our ImmunoTek family. Each Associate plays an important role in making the workplace thriving and enjoyable.
We are extremely grateful for the plasma donors who have decided to make ImmunoTek a part of their lives, visiting us weekly and becoming part of our business family.
We are dedicated to supplying the highest quality plasma used in medications for patients all over the world.
Supervisory responsibility of Senior Operations Managers, Center Directors and Quality Assurance Managers for training, production, cost and operations in assigned Donor Centers. Actively participate in maintaining quality operations throughout.
ESSENTIAL JOB FUNCTIONS:
Operations & Training
Utilizing Senior Operations Manager, Center Director, and associated Quality Assurance Manager, develop, integrate, streamline and simplify center operations, with consideration of the impact on Quality, Training and Compliance.
Responsible for the identification, evaluation and hiring of candidates for available center management team positions.
Assist RA/QA in the development and integration of new/revised SOPs and Quality Systems.
Through management of the assigned Senior Operations Manager and in coordination with the Senior Director of Operations, support the company training goals through development/modification of training materials for SOPs or other training initiatives and development of center management and employees.
Train new Center Directors and Senior Operations Managers as needed.
Report status of assigned centers to the Senior Director of Operations in a timely and consistent manner.
Submit timely and accurate reports as necessary.
Responsible to assure assigned Donor Centers continuously meet regulatory, customer and SOP requirements.
Responsible for budget preparation for designated Region and to ensure facilities operate within the agreed-upon budget.
Provide strategic direction, planning and customer focus to assigned Center Directors and Senior Operations Managers.
Responsible for the evaluation and determination of an employee's competence to perform required job functions throughout the training process and with periodic employee observations.
With direction from the Senior Director of Operations, create weekly, monthly and annual production and profit targets. This includes all associated activities within the Region to assure targets are met, such as developing effective donor and employee recruitment campaigns and performing impact analysis on proposed wage and donor fee changes
Continuously monitor and evaluate operations at assigned centers and provide feedback including, but not limited to, suggestions for changes and assistance in implementing the changes.
Develop skills of assigned Senior Operations Managers and Center Directors.
Manage supply ordering system to assure compliance with budgeted targets.
Through assigned personnel, manage operational audit process within Region assuring compliance with all company policies. In coordination with VP, Quality Assurance, develop and execute cross Regional internal compliance audit schedule.
Ensure operation of assigned centers is in compliance with customer requirements.
Maintain thorough familiarity with State and Federal regulations, European regulations, FDA approved Standard Operating Procedure manual, OSHA, CLIA, cGMP and customer requirements.
Review SOP revisions and assure all are implemented effectively within Region.
Keep immediate supervisor informed of any irregularities within the Region and provide constructive information about process improvements.
Minimize company liability through constant risk management review.
Through Senior Operations Managers and with direct interaction, provide supervision of the Center Directors in the Region. Provide direct supervision to Quality Assurance Manager related to QA compliance in designated centers. Communicate with Senior Director of Operations and Corporate Management where necessary on Donor Center issues.
Assure appropriate training of Senior Operations Managers and Center Directors.
Monitor centers performance through direct and indirect contact which includes frequent on-site visits.
Create and foster good communications and team approach with Immunotek Operations and QA staff.
Inspections and Audits
Interact with Senior Operations Managers, Center Directors, Quality Assurance Managers and Donor Center personnel to facilitate corrective actions for inspection findings.
Implement Quality initiatives to ensure no major observations are noted during internal and external inspections, audits of designated centers.
Assist Senior Operations Managers and Center Directors to ensure no repeat observations exist throughout designated centers operations.
Additional Duties and Responsibilities:
May be assigned to train or work with new personnel at all levels.
May be assigned to assist in other areas as needed.
Maintain the certification and ability to manage Donor Centers when
Supervises the Senior Operations Managers, Center Directors and Quality Assurance Managers in a specified Region. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
College Degree preferred. Minimum three (3) years' experience in biologics/plasma center operations and/or FDA regulated enterprise required. Previous experience should demonstrate expertise in plasma center operations, understanding of plasma center cost models and components, performance of operational analysis/audits, as well as an understanding of quality control principals, cGMPs, FDA regulations, and SOP implementation.
Strong leadership, organizational, interpersonal, written and verbal communication skills required. Demonstrate self-motivational ability and be able to work with minimal supervision. Must be able to write legibly and intelligently. Must be able to use PC effectively and be capable of working with Word and Excel documents. Must be able to travel 75% to 100% of the time as required.
Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand; walk, climb or balance; and stoop, kneel, crouch, or crawl.
Ability to travel via automobile and/or airplane. Able to stand for extended periods of time - up to four (4) hours at a time. Capable of viewing a video display terminal less than 18" away from face - up to four (4) hours at a time. Must be able to lift, tug, or pull up to fifty (50) pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate. May be exposed to short periods of time to freezing temperatures. Occupational exposure to bloodborne pathogens.