Manager - Clinical Lab Quality & Regulatory Assurance

Manager, Clinical Lab Quality & Regulatory Assurance

VENN LABS (UAB/SR Collaboration)

Birmingham, Alabama

General Summary

A joint venture from the University of Alabama-Birmingham (UAB) and Southern Research will establish a new clinical diagnostics lab and operation, Venn Labs, by integrating current services into one unified diagnostics lab. Venn Labs operations will consist of Biochemical Genetics, Cytogenetics, Pediatric Virology, Molecular Diagnostics, and Molecular Genomics. The Manager of Clinical Lab Quality & Regulatory Assurance, a keystone professional, heads our quality and regulatory team to help in both baseline integration and future quality/regulatory strategies to ensure business compliance.

Essential Duties & Responsibilities

• Implement and own the sites Quality Management System (QMS) and assure compliance with federal and state regulations.
• Help develop and deploy both short- and long-term company and departmental regulatory/business strategies in a "compliance is a must" business culture.
• Work with lab departments to identify and operationalize quality assurance metrics; including, but not limited to, proficiency testing, training, corrected/amended report processes, and general policies to meet regulatory requirements.
• Act as the main contact for appropriate federal and state authority regulatory bodies to meet respective standards, registrations, inspections, reporting and formal communications with College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA) and others as defined by business need.
• Oversee nonconforming event management: review and documentation of nonconforming events; investigations, root cause analysis, and corrective and preventive actions.
• Oversee the laboratory feedback and complaint process, including management of escalations and data trending.
• Ensure adequate resources are identified to participate in activities including, but not limited to, performing gap analysis, risk management, document control, audits, inspections, and process creation and improvement
• Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
• Apply exceptional written and verbal communication skills.
• Apply a strong attention to detail; apply organizational and record-keeping skills.
• Ability to lead across functions with both internal and external stakeholders
• Apply strong leadership and decision-making skills; ability to communicate ideas, opinions, and counterarguments in a proactive and professional manner.
• Other duties as assigned.

Requirements/Minimum Qualifications

• Bachelor's Degree in a scientific field related to the essential duties of the position or relevant work experience required.
• 4+ years of quality systems and/or quality assurance experience in clinical/device related background.
• 2+ years of experience working in a clinical laboratory or other regulated environment with demonstrated strong understanding of regulations to include CAP, CLIA, patient privacy, or with FDA.
• 1+ year of experience in leading and managing teams with demonstrated success.
• Experience working with process and project implementation, management, or improvement.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience with or demonstrated understanding of specific state regulatory requirements for clinical laboratory operations in Alabama and/or others.
• Experience working with Laboratory Information Systems.

Core Values

Cultivating human connection - putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.

Operating with precise execution - measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.

Harnessing relentless curiosity - our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.

Stewarding a healthy community - implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.

Job Specific Behaviors

Communicates Effectively for Influence - Writes, speaks, listens and presents information effectively and persuasively across

communication settings. Asserts own ideas and persuades others to commit to action.

Consultation Skills - Ability to consult effectively with employees at all levels within the organization to identify needs or address concerns.

Compliance -Applies an understanding of key legal precedents, policies and practices to protect the interests of the organization.

Conflict Management - Possess an unbiased approach to confrontational situations and ensures that issues are resolved in a professional manner

Cross Team Collaboration - Ensures integration and cooperation across organizational boundaries

Customer Focus/ Value Creation - Responds to customer's needs in a manner that provides added value and generates significant customer satisfaction

Negotiation Skills - Negotiates or mediates sound agreements in business or organizational situations where there is disagreement or difference in interests.

Planning and Organization - Systematically identifies issues to be addressed and plans a course of action for self and others to ensure the accomplishment of specific task objectives

Project Management (general) - Ability to plan, monitor and control projects ensuring efficient utilization of technical and administrative resources.

Technical Knowledge -Awareness of pension and benefit plans, conformance requirements for local, state and federal benefit, labor and employment laws and regulations.

Tolerance for Stress, Ambiguity and Change - Demonstrates flexibility in applying different approaches to changing work demands.

Vendor Performance Management - Ability to develop and sustain effective relationships with our external vendors/suppliers.

Physical Demands

• This position is required to work in an office setting using a computer for extended periods of time.
• Personal involvement and exposure, including travel, to other locations is required.
• This position includes entry to laboratory or workspace areas that will require use of appropriate PPE.

Certifications, Licenses & Registrations

• None required