Director, Regulatory & Accreditation Compliance

If youre ready to be part of our legacy of hope and innovation we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered.

Day - 08 Hour (United States of America)

This is a Stanford Blood Center job.

A Brief Overview
Reporting to the Vice President the Director of Regulatory and Accreditation Compliance is responsible for Stanford Blood Centers (SBC) Quality and Regulatory Affairs (QRA) department. Employing cGMP ensure SBC is in compliance with all federal state and local laws and regulation/accreditation requirements regarding blood GMP/HCTP collection and testing facilities and all health and safety policies and procedures. Lead development of strategic goals for QRA department to support SBCs overall goals.

Locations
Stanford Blood Center

What you will do

• Compliance Ensure compliance to current regulations and accreditation requirements by federal state county and accreditation agencies. Also ensure plasma fractionator specifications and inspection requirements are satisfied for SBC and for NBTC clients in relation to using our testing facility.
• Quality Assurance / Training / GMP / GTP/ GLP Lead quality activities initiatives and process improvement activities
• Team Leadership Manage the performance of direct reports. Set team objectives priorities and resources to align staff with Blood Center objectives. Responsible for interviewing hiring training coaching performance management and performance reviews of direct reports.
• Quality Management System Manage use of EtQ quality management system and optimize its use
• Registration and Licensure Update and submit registration and licensing requirements for all SBC establishments
• Safety Provide oversight on the safety emergency and disaster management of the organizations

Education Qualifications

• Bachelors Degree in a work-related discipline/field from an accredited college or university Required

Experience Qualifications

• 5 years to 7 years of supervisory experience Required

Required Knowledge Skills and Abilities

• Ability to communicate effectively both orally and in writing
• Ability to provide leadership and influence others
• Ability to foster effective working relationships and build consensus
• Ability to plan organize prioritize work independently and meet deadlines
• Exceptional attention to detail
• Ability to mediate and resolve complex problems and issues
• Ability to plan organize prioritize work and meet deadlines
• Ability to work independently able to analyze and evaluate complex situations and initiate improvement ideas to enhance quality and safety programs.
• Ability to supervise coach mentor train and evaluate work results
• Strong computer skills and proficient in Microsoft office applications.
• Knowledge of principles and practices of strategic planning quality improvement program evaluation hospital administration and healthcare financial management
• Knowledge of state and federal regulatory requirements related to healthcare compliance
• Knowledge of statistical analysis and reporting practices pertaining to quality improvement and program evaluation

Preferred Knowledge Skills and Abilities

• One or more of the following desired: Medical Technology certification Registered Nurse Specialist in Blood Banking (SBB) certification CQA certification Quality Management tools (FMEA root cause analysis etc) or Quality manufacturing tools (Lean Manufacturing Six Sigma etc.).

Physical Demands and Work Conditions

Physical Demands

• Frequent Sitting.
• Frequent Walking.
• Frequent Standing.
• Occasional Bending.
• Occasional Squatting.
• Seldom Climbing.
• Occasional Kneeling.
• Seldom Crawling.
• Constant Hand Use.
• Frequent Repetitive Motion Hand Use.
• Constant Grasping.
• Constant Fine Manipulation.
• Constant Pushing and Pulling.
• Seldom Reaching (above shoulder level).
• Occasional Twisting and Turning (Neck and Waist).
• Frequent Vision (Color Peripheral Distance Focus).

Lifting

• Seldom lifting of 0 - 10 lbs.
• Never lifting of 11 - 20 lbs.
• lifting of 21 - 30 lbs. 0 to 0 in height
• lifting of 31 - 40 lbs. 0 to 0 in height
• lifting of 40 lbs. 0 to 0 in height

Carrying

• Seldom lifting of 0 - 10 lbs.
• Never lifting of 11 - 20 lbs.
• lifting of 21 - 30 lbs. 0 to 0 in height
• lifting of 31 - 40 lbs. 0 to 0 in height
• lifting of 40 lbs. 0 to 0 in height

Blood Borne Pathogens

• Category III - Tasks that involve NO exposure to blood body fluids or tissues and Category I tasks that are not a condition of employment

These principles apply to ALL employees:

SHC Commitment to Providing an Exceptional Patient & Family Experience

Stanford Health Care sets a high standard for delivering value and an exceptional experience for our patients and families. Candidates for employment and existing employees must adopt and execute C-I-CARE standards for all of patients families and towards each other. C-I-CARE is the foundation of Stanfords patient-experience and represents a framework for patient-centered interactions. Simply put we do what it takes to enable and empower patients and families to focus on health healing and recovery.

You will do this by executing against our three experience pillars from the patient and familys perspective:

• Know Me: Anticipate my needs and status to deliver effective care
• Show Me the Way: Guide and prompt my actions to arrive at better outcomes and better health
• Coordinate for Me: Own the complexity of my care through coordination

Equal Opportunity Employer Stanford Health Care (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination inall ofits policies and practices including the area of employment. Accordingly SHC does not discriminate against any person on the basis of race color sex sexual orientation or gender identity and/or expression religion age national or ethnic origin political beliefs marital status medical condition genetic information veteran status or disability or the perception of any of the above. People of all genders members of all racial and ethnic groups people with disabilities and veterans are encouraged to apply. Qualified applicants with criminal convictions will be considered after an individualized assessment of the conviction and the job requirements.

Base Pay Scale: Generally starting at $91.60 - $121.38 per hour

The salary of the finalist selected for this role will be set based on a variety of factors including but not limited to internal equity experience education specialty and training. This pay scale is not a promise of a particular wage.