Pharmadx Director Quality

Schedule:

Monday- Friday (40 hrs/wk)

8:00 AM - 5:00 PM

Department: PharmaDx Quality- 506

Primary Purpose:

The PharmaDx Director of Quality has responsibility for developing, implementing, maintaining, and continually improving the PharmaDx Quality Management System (QMS). Together with the Vice President of Clinical Trials and PharmaDx and the Quality Systems and Support corporate function, the Director is also responsible for developing and implementing the quality strategy for the PharmaDx Department. This role supports the establishment and execution of sustainable processes, assures informed relationships with internal and external stakeholders, and delivers strategic outcomes. This role oversees a team of quality assurance professionals who perform required quality assurance tasks and act as liaisons with internal and external colleagues. The Director provides critical guidance for QMS change management, supplier management, continuous improvement, and medical device QMS audit processes for PharmaDx. Together with counterparts supporting clinical lab operations (ISO 15189, CAP/CLIA) and the clinical investigations team (GCP) this role is responsible for ensuring ongoing compliance to applicable regulations and standards (e.g., ISO, FDA, IVDD/IVDR, GMP, international regulatory standards, etc.) and supporting the quality of the manufacturing processes and device clinical trials performed by the PharmaDx group. This role acts as a Quality Management Representative (QMR) and reports directly to the Chief Quality Officer with a secondary reporting line to the Vice President, Clinical Trials and PharmaDx. They work with limited supervision and wide latitude for independent judgment and decision-making.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Performs all work in compliance with applicable Corporate and PharmaDx QMS procedures.

With input from area subject matter experts, ensures that PharmaDx QMS requirements are effectively established and maintained in accordance with applicable U.S. and international regulations.

Ensures the awareness of PharmaDx regulatory and QMS requirements where applicable throughout the organization.

Maintains an understanding of the corporate QMS and PharmaDx's role within.

Implements QMS-level changes necessary for maintaining PharmaDx QMS compliance with regulatory and organizational requirements.

Ensures maintenance and review of PharmaDx QMS metrics.

Provides direction and delegates responsibility to staff; ensures ownership of tasks while holding team members accountable.

Provides input and guidance to interdepartmental project teams on QMS Med Device and other high-level regulations and guidelines.

Hires, develops, and retains staff, providing them with opportunities for professional growth.

Mentors project team members in communicating with regulatory bodies for quality-related activities (e.g., planning and leading a regulatory inspection).

Uses experience and expertise to challenge assumptions and invent solutions to Quality issues, concerns, and roadblocks that may arise throughout the product lifecycle.

Provides input on quality related provisions in contracts.

Demonstrates knowledge of applicable regulatory requirements of US and international regulatory agencies.

Responsible for ensuring the PharmaDx QMS is followed by staff within the PharmaDx Department.

Provides leadership and guidance for the quality assurance aspects of PharmaDx manufacturing activities.

Provides leadership and guidance for the quality assurance aspects of PharmaDx device clinical trials.

Provides leadership and guidance for quality assurance functions to ensure that testing methods comply with all guidelines and enforces compliance.

In collaboration with the Quality Director of Corporate Programs, provides regulatory support for FDA-related issues in ARUP clinical laboratories as needed.

May prepare for and host regulatory inspections and assessments related to PharmaDx device activities (e.g., FDA, Notified Body).

Leads PharmaDx Management Review meetings.

Maintains professional relationships with all relevant internal and external stakeholders.

Accountable for PharmaDx Quality department budget. Partners with Quality Officer and VP, Clinical Trials and PharmaDx to ensure quality group staffing is appropriate to meet business needs.

Other duties as assigned.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.