Director of Quality and Regulatory at uBiome
San Francisco, CA, US
uBiome is a great place to work.
uBiome’s mission is to transform information about the microbiome into useful products and services that improve people’s lives.
We offer Medical, Dental, and Vision benefits, as well as an FSA and a 401k with matching. We give our employees meaningful equity, unlimited vacation, and lunch every day. Our kitchen is stocked with all kinds of awesome stuff, and we’re very generous when it comes to cheese (vegan and gluten-free options also available).
We are an equal opportunity employer that believes guts diverse in bacteria and companies with diverse humans both make for better environments.
We are looking for a Director of Regulatory and Quality to oversee and manage our laboratory quality and compliance activities. In this role, you’ll be in charge of fun acronyms like CLIA, CAP, ISO15189, HIPAA, and other regulatory areas. In this position, your primary interests will be compliance, compliance, and compliance. Whether it’s federal, state, and professional standards, or clinical operations regulations, your favorite place to be is in compliance. You’ll get us there if we’re not, you’ll develop policies and procedures that put us there as they’re newly created, and you’ll maintain, revise, and oversee audits to keep us here so we can all bask in the glory of compliance.
In this position, some of the many hats you’ll wear are:
HIPAA Privacy Officer. This hat will give you the ability to oversee all ongoing activities related to the development, implementation, maintenance of, and adherence to the organization’s policies and procedures covering the privacy of, and access to, protected health information in compliance with federal and state laws and the organization’s information privacy practices
Compliance Head Cheerleader. This hat draws the attention of anyone who has questions about regulatory or compliance, and doubles as a megaphone so you can promote best practices and new processes
Quality Management Program Fanclub President. This hat helps you protect the company from the dreaded land outside compliance and regulations, and helps you oversee the programs that provide the guidelines to which we all adhere
You might get the reputation for being mildly clairvoyant because your ability to identify, address, and mitigate potential gaps or issues before they arise is uncanny (we won’t let the secret out that you’re just super methodical with your awesome quality improvement process).
Your new best friends will be:
Customer support. They know you have their backs, and you’ll build strong relationships with them by helping them achieve transcendent states of customer satisfaction through timely regulatory processes and updates
The VP of Laboratory Operations and Quality. She’ll be your boss and is all around amazing. You’ll work closely with her and other members of the executive team to collaborate on various projects
The Regulatory and Quality Management Teams. They’ll be your #squad and you’ll develop, mentor, and guide them in the science and art of compliance.
All the people at uBiome that you’ll work to educate on regulatory needs and who will adopt your best practices of continuous quality improvement and operational excellence.
You’re the ideal candidate for this position if you have a BS or BA in a scientific field, and although it’s not required, you get a gold star and extra credit for a PhD or MS/MA. You’re probably used to fast-paced organizations, and have managed and lead a team in one for at least 5 years. You have comprehensive knowledge of federal and state regulations that impact clinical operations, including HIPAA, CLIA, CAP, ISO15189, NY-CLEP, and other important regulations in all caps (and maybe some in regular case, too). You’re comfortable using things like MS Office and GoogleSuite. We’re excited to hear about a time that you thought outside the box to get a complicated project done on time, building meaningful relationships and knowledge along the way. You get double extra bonus points if you’re licensed in the State of California for Patient Testing. We’d also love for you to have experience managing a company process of handling complaints.
In your first week, you’ll….
Communicate with regulatory agencies and customers on matters relating to complaints and member grievances
Start to build strong relationships with employees that promote trust and respect
Utilize a project management approach for interdepartmental and interdisciplinary projects to facilitate comprehensive and timely completion of assignments
Coordinate with managers for preparation and training on relevant regulatory requirements and provisions and preparation for accreditation cycles
In your first quarter, you’ll…
Be responsible for tracking and reporting on federal and state legislation that impacts uBiome’s products or operations
Develop project plans that assure compliance is achieved within specified deadlines
Provide timely regulatory and professional information, consultation and compliance resources to the organization and to customers
Monitor and promote compliance with applicable laws, regulations, and guidelines and performance measures and quality improvement goals
Oversee, coordinate, and monitor laboratory quality management tracking for defined performance measures and quality improvement projects to drive operational excellence with focus on improved quality and customer satisfaction
In your first year, you’ll….
Evaluate current policies, procedures and regulatory-specific education and training for company employees and contractors and, as needed, develop or revise such policies, procedures and education/training offerings
Assess and modify current processes to improve compliance, department response time, service quality, risk mitigation, organizational effectiveness and completion of corrective action plans, following up on the status of key compliance or quality management initiatives
Provide leadership and focused reviews in the specific areas of escalated and complex issue management to include coordination with managers and key stakeholders to assure root cause analysis and appropriate action taken in areas of deficiency or lack of adherence to policy and procedure
Monitor, support and ensure effective implementation of the following quality systems: compliance and quality committees and activities, management of complaints, grievances, training, internal audits, data and trend analysis