Overview:
This role is responsible for ensuring the quality and safety of NYBCe products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. This role will contribute to the design, implementation and management of the quality management system and lead QMS related projects and teams. This position serves as an expert resource, providing quality oversight and ensuring regulatory and accreditation compliance across multiple program areas, including blood and cellular therapy products manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research, as well as organization-wide support functions such as information systems, facilities, and safety.
Supervision Exercised:
This position supervises staff.
Supervision of Positions:
Under general supervision of assigned managerial staff.
Responsibilities:
Primary Duties, Responsibilities or Activities Required by Job
- Manage programs and projects in assigned areas, including setting goals, measuring and reporting on performance, managing resources and budget
- Supervise staff, including work assignments, performance review, time and attendance, training, and mentoring.
- Protect the safety of patients and blood or HCT/P donors by notifying management and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
- Contribute to the design and takes a lead role in the implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned.
- Lead and independently perform quality assurance activities in support of NYBC enterprise-wide program areas.
- Ensure that appropriate specifications for NYBCe services and products have been defined according to their intended use, and verify that they consistently meet these defined specifications.
- Confirm that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy.
- Verify that document management and record keeping systems comply with regulatory and accreditation requirements.
- Review and approve validation studies for critical processes, equipment and computer systems to assure that they will consistently perform as expected.
- Verify that outside suppliers of reagents, materials and services used in critical processes are qualified according to NYBCe standards.
- Assist operational staff in the identification and reporting of deviations.
- Advise operational staff in root cause analysis, and the development of effective corrective action, preventive action, and effectiveness verification plans.
- Lead external regulatory and accreditation inspections, including preparation and follow up activities.
- Independently monitor and assess quality performance and compliance of operational systems.
- Manage deviation reporting process, including classification, analysis and follow up
- Lead or participate in quality audits. Schedule and assign staff resources.
- Perform focused quality assessments of operational processes
- Track, trend, analyze and report quality and process performance data
- Contribute to process improvement efforts and lead team projects as needed.
- Advise staff on the development of corrective action and preventive action plans.
- Perform verification and effectiveness checks for CAPAs.
- Identify opportunities for improvement and make recommendations based on monitoring and assessment activities.
- Participate on formal process improvement team projects as assigned.
- Leads or actively participate in regularly scheduled quality management system review meetings with operational staff and managers.
Other Secondary Functions
- Assist with implementation, maintenance and monitoring of environmental health and safety activities as assigned.
- Work on special projects, individually and in a team, as assigned.
- Support management and/or serve as a system administrator of the eQMS software application and quality databases
- Any related duties as assigned.
Location Specific Details
The incumbent may perform specialized duties requiring advanced or specialized knowledge and abilities in one or more of the following disciplines:
- Regulatory Affairs related to Blood, HCT/Ps, Medical Devices, CLIA, Distribution Pharmacy, and/or Clinical Trials at the State and Federal levels
- Environmental Health and Safety Program
- Document and Records Management Program
- Education and Training Programs
- Software application configuration management / database management
Qualifications:
Education: Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelor’s degree in another field of study may be considered with strong, relevant work experience Related Experience: Minimum five years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting). Minimum six years total relevant experience (includes any combination of: 1) specialized experience described above, and 2) clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting). Minimum one year management experience (includes supervision, project management, and/or program management OR Any combination of education and experience that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the requirements above. |
Preferred Qualifications
ASQ, Six Sigma or Lean Certification is a plus.
Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
Required Licenses / Certifications
Valid Driver's license with an acceptable driving record (preferred)
Required Knowledge, Skills & Abilities
Knowledge:
- Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
- Expert knowledge of regulations and accreditation standards applicable to the NYBC program units supported, including blood and tissue establishments, and clinical laboratories.
- Working knowledge of business unit/program area(s) supported - operational principles and practice.
- Working knowledge of organizational management principles and practices.
- Strong working knowledge of current business productivity software applications.
Skills:
- Expert skills to apply knowledge of, and interpret applicable Federal, State, Local and international regulations and standards, technical specifications, and other guidelines to evaluate compliance.
- Strong interpersonal skills and professional demeanor.
- Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse background.
- Self-starter while working well in a strong team environment.
Abilities:
- Expert ability to conduct studies and investigations, problem analysis, and risk assessments to develop logical and well-documented recommendations.
- Expert ability to analyze and interpret observational, operational and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
- Expert ability to conduct studies and investigations, problem analysis, and risk assessments to develop logical and well-documented recommendations.
- Ability to prepare and deliver clear, concise, and effective written and oral communications, and to listen effectively.
- Ability to effectively manage multiple assignments while adhering to strict deadlines.
- Collaborate with others and work effectively in a team environment.
- Ability to lead a team.
- Make sound independent decisions by applying policies and procedures and using available resources.
- Identify and implement actionable steps to resolve problems.
