Compensation:
$96,349-$108,392, exempt.
Additional Compensation:
Variable Pay Bonus Plan, per plan document
Benefits: Donor Alliance prides itself on its robust benefit package. Employee-only coverage for health, vision, and dental totaling only $22.00/month.
Health insurance
Dental insurance
Vision insurance
401k Retirement plan
Paid Time Off
Student Loan Repayment
Variety of voluntary benefits
To see a comprehensive look at Donor Alliance’s benefits package, click here to visit our website.
Donor Alliance prides itself on competitive compensation and excellent benefits package!
Equal Opportunity Employer
Additional Information:
Employer will assist with relocation costs.
Internal Number: 001
Donor Alliance is hiring a Regulatory Compliance Manager in Denver! The Regulatory Compliance Manager promotes regulatory compliance and provides comprehensive monitoring and analysis of current and impending regulations and industry standards. This position is responsible for managing the day-to-day activities for the organization’s quality program, including but not limited to the organization’s audit, corrective and preventive action (CAPA), nonconformance reporting (NCR), complaint management reporting (CMR), adverse event reporting, document control, deviation management, and supplier management systems. This position also leads and manages processes and systems to support the collection of performance improvement data and data reporting to external organizations as directed.
Day-To-Day
Leadership:
Actively engages in monthly leadership meetings.
Actively engages in strategic thinking and performance improvement processes to support the organizations Mission and Goals.
Utilizes the department scorecard information to drive departmental performance improvement.
Actively engages in Baldrige, Huron, Leadership Training, Strategic Planning Meetings and assigned projects.
Performs rounding and 1:1 meetings with direct staff on a monthly basis.
Assists in recruiting and selecting applicants for job vacancies considering the requirements of the job and the skills/abilities of the applicant.
Communicates with department director regarding performance issues and establishes coaching plans as appropriate.
Leads meetings with focus on department metrics and strategic objectives.
Oversees training of staff and, if applicable, annual competency assessments.
Partners with department director in budget creation and analysis.
Manages, evaluates, and develops direct reports, including recruiting, hiring, performance appraisals, training, workloads, and initiates corrective and/or disciplinary actions.
Manages relevant documentation (electronic time records, expense reports, seminars, and PTO requests).
Promotes the Mission, Vision, and Core Values of Donor Alliance.
Maintains confidentiality of all donor, recipient, and employee information.
May perform other related duties as required to meet the ongoing needs of the organization.
Regulatory Compliance:
Promotes and assures organizational compliance with regulatory agencies and industry standards (i.e., CMS, FDA, OPTN, AATB, CLIA) by ensuring activities of a comprehensive quality program are carried out.
Collaborates with the director and appropriate staff to monitor and analyze regulatory, accreditation and legislative standards for impact on business operations. Maintains awareness of trends and changes.
Collaborates with the Leadership Team, Donor Alliance staff, external customers, suppliers/vendors, and partners to ensure that compliance standards are met.
Maintains and proposes new systems/processes and modifications to enhance quality and compliance of the organization. Takes initiative in recommending and/or implementing improvements.
Oversees Donor Alliance’s document control system to ensure appropriate confidentiality, security, tracking, release, storage, retrieval and retention of standard operating policies and procedures (SOPPs).
In conjunction with leadership, participates in the development, review, and implementation of SOPPs to safeguard organizational compliance.
Reviews SOPPs to ensure alignment with business practices and regulatory requirements.
Provides oversight of Donor Alliance’s Corrective Action/Preventative Action (CAPA), Non-Conformance Report (NCR), and Complaint Management Report (CMR) systems to ensure that events are documented, investigated, tracked, monitored, and closed appropriately.
Assists in investigations involving the potential for quality or risk related issues and recommends CAPA initiation as indicated.
Engages in root cause analysis and resolving quality concerns and issues as needed.
Assists with and/or participates in the reporting of adverse events, deviations, and information that may impact donor eligibility or recipient safety (i.e. possible contamination or potential for transmission of a communicable disease)
Oversees the development and maintenance of required protocols involving laboratory testing devices.
Coordinates internal processes to align with CLIA regulations.
Collaborates with the Lab Director, Director of Clinical Management, clinical and recovery center personnel to manage the CLIA program, including processes and documentation for laboratory performance verifications, proficiency testing, and laboratory equipment.
Ensures the maintenance and retention of quality system documentation.
Oversees the retrospective medical record review process to assess and maximize opportunities for organ donation.
Promotes performance measurement, donor/recipient safety, and data-driven quality improvement.
Collects and analyzes data (i.e. audits, nonconformances, complaints, CAPAs, deviations, adverse event reports, medical record review) to support regulatory compliance, quality assurance, and performance improvement.
Provides training to Donor Alliance staff on topics related to regulatory compliance and aspects of the quality management system.
Acts as a platform administrator for the organization’s electronic quality management system (eQMS).
Participates and engages in quality improvement projects.
Qualifications
Bachelor’s degree or equivalent of education and work experience in relevant field required.
Minimum five years quality management/performance improvement experience required.
Minimum three years auditing within a regulatory environment (i.e. CMS, FDA, etc.) required.
Minimum of three years of management experience preferred.
Certification through organizations such as American Society of Quality (ASQ) or National Association for Healthcare Quality (NAHQ) is desired.
Previous experience with Quality Management System software (i.e. Q-Pulse) is preferred.
Proficiency in the use of computer equipment and software, including but not limited to MS Office environment (Word, PowerPoint, Excel, Outlook - intermediate to advanced skills) is required.
Strong interpersonal skills with the ability to work both independently and as part of a team is required.
Ability to communicate effectively and interact positively with all levels of management and staff.
Strong analytical and critical thinking skills.
Excellent written and verbal communication skills.
Strong time management skills with ability to concurrently manage multiple projects.
Strict confidentiality, high ethical standards, excellent use of judgment, and discretion required relative to sensitive and restricted organizational information
Donor Alliance is the federally-designated, Association of Organ Procurement Organizations (AOPO) and American Association of Tissue Banks (AATB) accredited, non-profit organ procurement organization serving Colorado and most of Wyoming. As a recognized leader in facilitating the donation and recovery of transplantable organs and tissues, Donor Alliance’s mission is to save lives through organ and tissue donation and transplantation. To achieve this mission, Donor Alliance employs effective family approach and recovery programs in more than 100 hospitals. Donor Alliance also inspires the public to register as organ and tissue donors through community partnerships, public outreach and education campaigns throughout its donation service area.
Qualifications
Bachelor’s degree or equivalent of education and work experience in relevant field required.
Minimum five years quality management/performance improvement experience required.
Minimum three years auditing within a regulatory environment (i.e. CMS, FDA, etc.) required.
Minimum of three years of management experience preferred.
Certification through organizations such as American Society of Quality (ASQ) or National Association for Healthcare Quality (NAHQ) is desired.
Previous experience with Quality Management System software (i.e. Q-Pulse) is preferred.
Proficiency in the use of computer equipment and software, including but not limited to MS Office environment (Word, PowerPoint, Excel, Outlook - intermediate to advanced skills) is required.
Strong interpersonal skills with the ability to work both independently and as part of a team is required.
Ability to communicate effectively and interact positively with all levels of management and staff.
Strong analytical and critical thinking skills.
Excellent written and verbal communication skills.
Strong time management skills with ability to concurrently manage multiple projects.
Strict confidentiality, high ethical standards, excellent use of judgment, and discretion required relative to sensitive and restricted organizational information
Donor Alliance is the federally-designated, Association of Organ Procurement Organizations (AOPO) and American Association of Tissue Banks (AATB) accredited, non-profit organ procurement organization serving Colorado and most of Wyoming. As a recognized leader in facilitating the donation and recovery of transplantable organs and tissues, Donor Alliance’s mission is to save lives through organ and tissue donation and transplantation. To achieve this mission, Donor Alliance employs effective family approach and recovery programs in more than 100 hospitals. Donor Alliance also inspires the public to register as organ and tissue donors through community partnerships, public outreach and education campaigns throughout its donation service area.