Sr. Director of Quality Management

Health Catalyst

Remote
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/02/2021
  • Website: healthcatalyst.com
  • Company Address: 3165 East Millrock Drive Suite 400, Salt Lake City, UT, 84121

About Health Catalyst

Comprehensive performance management and predictive analytics platform for health systems

Job Description

Our mission is to be the catalyst for massive, measurable, data-informed healthcare improvement through:

Data: integrate data in a flexible, open & scalable platform to power healthcare’s digital transformation​
Analytics: deliver analytic applications & services that generate insight on how to measurably improve​
Expertise: provide clinical, financial & operational experts who enable & accelerate improvement​
Engagement: attract, develop and retain world-class team members by being a best place to work​

Role: Sr. Director of Quality Management

Location: US Remote

Travel: 25-30%, US

Job Summary

The Senior Director of Quality Management oversees executing, maintaining and refining the Quality and Risk initiatives as directed by the Chief Quality Officer.  This is a hands-on operational role of managing ongoing quality, operational and compliance risks at Health Catalyst. This position will both manage and provide leadership to direct reports and dotted line reports managing Quality throughout Health Catalyst.

Internal facing roles include operational responsibility for the Quality Management Systems and supporting system from a quality perspective, operational and compliance risk processes. These include managing the operation of Quality-by-Design (QbD) projects, managing internal quality and compliance audits, and participating in customer and regulatory audits for vendor quality. Assists with the development of SOPs, specifications, policies and other quality documents as needed.

Require Proven Experience

Prior experience in a senior quality and risk position. Customer-facing experience is preferred.
Six Sigma or Total Quality Management  and Project Management experience is highly desired. Certification in these disciplines would be a plus.
Analytical skills for gathering data and analyzing the quality of the organization’s products and services.
Experience operating in a regulated environment such as 21 CFR § 11, 21 CFR § 820, 21 CFR § 200 or ICH equivalents. Experience operating in a 45 CFR § 164 regulated environment is highly desired.
Ability to collaborate with other groups, teams, and partners to implement quality programs, practices, and procedures across the organization.
Flexibility to adapt to Health Catalyst’s culture and mission, pace of operations and requirements.
Willingness to be on call to respond to company-related quality incidents and to travel domestically and internationally as needed.

Required Functional Skills

Excellent oral and written communication and presentation skills.
Highly collaborative as a team member
Extremely detailed oriented with excellent problem solving and critical thinking skills.
Dexterity to work with little supervision in a growing, fasted-paced environment.
Excellent time management skills to coordinate multiple tasks and meeting deadlines.

Primary Duties & Responsibilities

Execute a comprehensive Quality program strategy in line with Health Catalyst’s footprint, risk exposure, risk tolerance, organizational requirements, and business priorities as well as best practices, industry standards and applicable laws and regulations.
Operationalize Quality SOPs, policies, procedures, and work instructions.
Lead internal quality audits as needed.
Partner closely with Engineering, infrastructure, and applications team, to ensure that all applications are developed with Quality in mind.
Identify and mitigate Quality risks, defects, and directives across Health Catalyst’s ecosystem.
Function as a key advisor to other corporate teams for matters of policy violations and manage quality events; assist with legal matters associated with such violations, as necessary. Coordinate with external agencies as required.
Quality program management: You will be responsible for managing programs for the identification, reporting, and remediation of quality concerns throughout the organization.
Operate within the Quality & Risk budget and associated contracts, resources, and workforce.

Education & Relevant Experience

Bachelors, Masters or similar degrees in a field involving Quality

Project Management, PMP certification is preferred.
Six Sigma and/or Total Quality Management experience is preferred.
At least 4 years of experience in a hands-on management capacity.
Experience with Computer System Validation on cGCP, cGLP and cGMP systems, preferably large systems (e.g. ERP, MES, LIMS).
Poise and ability to act calmly and professionally in high-pressure, high-stress situations.
Experience in dealing with internal / external auditors and senior company management.
Demonstrated capabilities in innovation, problem solving, influencing, organizing and relationship building.

The above statements describe the general nature and level of work being performed in this job function.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned by Health Catalyst.

At Health Catalyst, we appreciate the opportunity to benefit from the diverse backgrounds and experiences of others. Because of our deep commitment to respect every individual, Health Catalyst is an equal opportunity employer.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.