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Regulatory Compliance Director

Company: BloodSystems
Location: Montvale
Posted on: June 10, 2021

Job Description:


Under minimal direction, this position is responsible for review of the quality systems and compliance in all areas of technical and clinical operations. Participates in operational excellence and other performance improvement initiatives. Oversees staff participation in performance improvement initiatives to include data and process analysis. Serves as a resource to operations on quality issues.


Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.

Assures quality customer service to all customers.

Maintains good attendance and punctuality per the absence policy.

Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.

Hires, supervises, trains, develops, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.

Conducts data and process analysis activities including in-depth analysis of deviation and operational performance data. Evaluates data for trends and opportunities for improvement and communicates this to operations management.

Ensures deviation management reports are accurate and timely and that events are coded correctly. Facilitates root cause analysis, reviews and approves corrective action, and performs effectiveness evaluations.

Participates in improvement initiatives and the use of improvement tools and methodologies. Serves as an improvement resource to operations.

Evaluates process change to include data collection and risk identification. Assists with development of risk mitigation steps.

Hosts external inspections. Assists in facilitating responses to observations. Ensures corrective actions were implemented and effective. Conducts risk assessments.

Supports the internal audit program and the performance of process based audits. Assists operations in evaluating observations, performing investigations, and conducting root cause analysis, and the development of corrective action. Performs follow-up on audit observations. Tracks responses, monitoring implementation, and ensures effectiveness of corrective action.

Participates on the review team to evaluate nonconforming products, materials, or test results and assesses impact on external customers. Ensures required actions are implemented.

Facilitates recalls and market withdrawals.

Assists in oversight of clinical study or research activities.

Coordinates staff review of documents to ensure processes are within control (e.g., QC data, validations, proficiency testing).

Participates in annual budget preparation and ensures adherence to approved department budget.

Performs all other duties, at the discretion of management, as assigned.


Knowledge/ Education

Bachelor's degree required.

Licenses/ Certifications

Certification as a Medical Technologist or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.


Five years of related experience in a regulated industry required. To include:

Two years of supervisory experience.

Three years of experience in quality, regulatory, and/or auditing.


Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.

Must be able to maintain confidentiality.

Must have analytical, statistical, personal organization, and problem solving skills.

Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate senior and executive-level managers.

Effective oral and written business communication skills.

Able to organize, prioritize, and execute a variable workload and multiple priorities.

Must have proficient computer skills.

Ability to work independently preferred.

Skills in performance improvement; data analysis; GMPs, HCT/Ps, and CLIA regs. preferred

Experience in a clinical setting (e.g., transfusion service, apheresis, or cell therapy) preferred.

  • EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail toaccommodation@bloodsystems.org or call 1-844-220-2612 to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.

For more EEO information about applicant rightsclick here

For information about Pay Transparency rightsclick here

Our organization participates in E-Verify, for more informationclick here

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.



Keywords: BloodSystems, Yonkers , Regulatory Compliance Director, Other , Montvale, New York

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