The Quality Assurance Director is responsible for ensuring all areas of the Blood Bank of Alaska are operating in compliance with applicable government regulations, accrediting agency standards or consignee requirements related to the collection, processing, testing and distribution of blood products, cellular therapy products and services. The QA Director participates as a member of the BBA management team in planning, program formulation, and systems development. The QA Director is responsible for designing, implementing, and monitoring the quality assurance program for all operating divisions of BBA.
The incumbent for this role must possess excellent conceptual, communication, and analytical skills. Must understand general work flow processes and equipment used in a medical facility. Must have excellent interactive skills necessary in communicating with co-workers and regulatory officials.
Major Responsibilities will include:
Establish and maintain aggressive compliance program that meets federal regulations, industry standards, and consignee or customer requirements. Oversee planning and implementation of quality assurance and operation projects.
Review current and new regulations, standards or proposed changes with regard for potential impact on operations or SOP’s. Review new and revised SOP’s and validations for compliance with appropriate regulations and standards.
Oversee and coordinate regulatory, accreditation and consignee inspections. Coordinate response with appropriate department managers.
Oversee, prepare and review correspondence related to FDA licensure and licensure applications.
Oversee internal audits. Audits may include BBA locations, processes, documentation, and supplier or service provider audits.
Provide guidance for training programs to ensure compliance with regulations and standards. Actively educate staff on cGMPs, cGTPs, regulations, standards, procedures and processes.
Establish and maintain oversight of system for prevention, detection, investigation, tracking, and corrective action of errors. Perform appropriate notification (e.g. FDA BPDRs or customer notifications) as appropriate.
Oversee investigations including: ORs, BPDRs, Q&LB, PDIRs, etc.
Oversee document control process and procedures. Work with the Document Control Specialists to ensure planning, implementation, tracking and review of all related documents follows appropriate policies and procedures.
Maintain authority to approve or reject blood components, cellular therapy products, and supplies and review production records.
Perform duties and promote compliance with all applicable regulatory and accrediting agencies. Ensure OSHA regulations, cGMPs and cGTPs are adhered to.
Follow all pertinent SOP’s that relate to this position. Document required information on appropriate records as needed.
Work with all departments to ensure that SOPs are followed, ensuring the safety of blood and cellular therapy products and compliance with FDA and AABB requirements.
Provide QA/compliance review of forms and documents as needed.
Oversee Quality Committee and create management updates.
Maintain positive communication with all departments. Promote a positive work environment in which staff work cooperatively towards objectives.
Assist management team in reviewing processes and recommending changes to improve quality.
Attend all relevant meetings as scheduled and able to attend.
Encourage employees to utilize appropriate support systems (SOPs, management, etc.) as necessary to resolve issues and answer questions.
Build employee morale through recognition, strong leadership, constructive feedback and performance appraisal.
Develop a team that embraces customer service. Focus on staff development in support of organizational objectives and standards. Identify professional development opportunities for applicable staff and self.
Perform performance evaluation and disciplinary review of applicable staff.
Make employee safety, timely reporting of safety issues and employee well-being a priority at all times.
Maintain open and positive communication with management and staff.
Exhibit support of BBA values, quality objectives, and customer service standards at all times. Promote the strategic direction of BBA to all employees.
Help maintain positive image of BBA throughout the community while maintaining overall corporate image.
Perform other duties as assigned and qualified to do.
Education and Experience:
Bachelor’s Degree (BA) in relevant field. American Society of Quality (ASQ) CQA preferred. Minimum five years in a highly regulated, compliance driven environment with responsibility and oversight for designing, implementing and monitoring the quality and compliance programs for all applicable divisions.
Certificates, Licenses, Etc:
Minimum: Valid Driver’s License. American Society of Quality (ASQ) CQA preferred.
About Blood Bank of Alaska
Blood Bank of Alaska and its donors are dedicated to serving the Alaskan community by providing safe, pure and potent blood products and laboratory services while meeting changing health care needs.