Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

Director's Administration

Job Summary:

Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our LDT efforts and meet all requirements.

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The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! This position is eligible for a $10,000 sign-on bonus and relocation assistance.

Shift:

Monday - Friday, 1st shift

Department Summary:

Our new 110,000-square-foot diagnostic core laboratory supports the needs of Vanderbilt University Medical Center's inpatient hospitals, outpatient clinics, regional hospitals, and extramural practice customers. Located five miles north of the 21st Avenue Nashville campus, the laboratory has expanded capacity to bring more testing to Vanderbilt, deploy innovative technology, improve patient care, and enhance team collaboration. The laboratory offers an expanded test menu supporting routine and specialized testing and aims to become the preferred reference laboratory provider in the southeast region.

Sign-On Bonus Requirement:

The sign-on bonus is not applicable to current VUMC staff or former staff who have worked for VUMC in the past twelve months. The sign-on bonus is only available for full-time positions.

Key Responsibilities:

• Monitors and coordinates responses to FDA LDT regulations.

• Develops work goals and objectives based on interpretation of FDA LDT regulations; plans to achieve goals or establish priorities through appropriate budgeting and program development.

• Develops team, policies, and processes to support this new area of the lab.

• The responsibilities listed are a general overview of the position and additional duties may be assigned.

Consideration may be given to candidates that can obtain certification within 120 days, in accordance with state guidelines.

Technical Capabilities:

• Clinical Expertise (Intermediate): Demonstrates working knowledge of FDA LDT regulations. Possesses sufficient knowledge, training and expertise to role model and coach less experienced staff.
  

• Business Results (Novice): Develops and implements appropriate measures for attaining well-defined business results and tracks progress in meeting goals and objectives. Continuously demonstrates a strong focus on quality in spite of time and other pressures. Anticipates and responds effectively to lab's needs. Sensitive to changes in the environment which may impact LDT regulations.
  

• Quality Management (Novice): Has provided continuous analysis and evaluation of assignment work processes, constantly striving for improvement in the way tasks and activities are accomplished by questioning their value to the process and contributing creative solutions. Has participated in the process of establishing, communicating and monitoring standards for quality and excellence. Demonstrates the ability to actually work on and improve a current business process, product or service.
  

• People Management (Intermediate): Successfully resolves conflicts and disciplinary problems. Provides counseling and career development planning to subordinates. Constructively gives timely positive and negative feedback, confronting individual performance problems in a professional and sensitive manner. Aware of the values, abilities and needs of others. Demonstrates the ability to create a positive work climate, establishing a feeling of partnership and empowering others. Has set, coached and assessed the assignment objectives of subordinates. Practices and rewards behaviors supportive of company values.
  

• Operations Planning (Intermediate): Demonstrates ability to forecast complex resource needs, identify discrete tasks, set priorities, define dependencies, schedule activities, meet deadlines, and organize work for a single functional area. Merges diverse points of view into a coalition with shared goals and objectives. Plans for and anticipates events outside of immediate responsibility. Identifies relevant stakeholders and gains their commitment. Anticipates problems and obstacles before they arise. Able to absorb changes to major assignments while maintaining a high level of performance. Competently handles multiple assignments and projects simultaneously. Sets priorities with a proper sense of urgency and importance. Develops creative ideas and takes innovative action to achieve planned goals and objectives.
  

• Compliance (Intermediate): Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.
  

• Leadership (Intermediate): Motivates and inspires others to perform at a high level. Puts aside personal needs and considerations for the good of the team. Communicates in a positive and constructive way, demonstrating an enthusiasm for team and unit goals. Takes appropriate risks, showing and accepting personal accountability for actions and decisions. Gets others to share challenges and perform as a valuable member of the team and unit. Accomplishes results through influence, coaching, communication and commitment with minimal use of authority and control.
  
  

Allied health is among the fastest growing occupations in healthcare today. This area can be defined as credentialed professionals who perform supportive, diagnostic, and therapeutic health care services to promote health and prevent disease in a variety of settings.

These areas are crucial to Vanderbilt Health's reputation for excellence in these areas that has made us a major center for patient referrals from throughout the Mid-South.

Each year, people throughout Tennessee and the southeast choose Vanderbilt Health for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.

Core Accountabilities:

* Organizational Impact: Directs activities to achieve operational plans with some near term effect on results of the department/area.* Problem Solving/ Complexity of work: Identifies issues, gathers facts to resolve technical and operational problems. * Breadth of Knowledge: Applies in-depth knowledge and skills of a professional/technical area and basic management knowledge to manage the work of the team.* Team Interaction: Leads a complex department with a focus on implementation. Typically executes on a short to medium term strategies.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences .Delivering Excellent Services : - Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them. - Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions. - Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly. - Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications:

LIC-Licensed Medical Laboratory Supervisor - Tennessee Medical Lab Board

Work Experience:

Relevant Work Experience

Experience Level :

5 years

Education:

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled