Sr. Director, Quality (Medical Device/IVD)
Company: Talis Biomedical
Location: Redwood City
Posted on: September 17, 2023
Sr. Director, Quality (Medical Device/IVD)
SUMMARY OF POSITION
The primary function of the Senior Director, Quality is to provide
leadership to assure the successful execution of Talis' Quality
program and to be responsible for developing, implementing, and
advising on strategies for development programs
- Directs Talis'Quality function responsible for the Company's
Quality System compliance with applicable regulatory agencies,
Quality pre-market product and operations support, and strong
functional leadership. Upon product launch, will be responsible for
post-market Quality System compliance,post market surveillance
including complaint monitoring, tracking and trending and
resolution with Commercial.
- Sets the strategy to meet quality system, validation of design
and design change. Champions design control rigor throughout the
Departmentincludingsettingprioritiesandstaffing. Hires, develops
and assures the Quality Department staff reviews/approves quality
documents that are in alignment with site Quality System and
- Implements, administers, and maintains the Company's document
controlsystem and responsible for
- Responsibleforriskmanagement (CAPA, Corrective Action Board,
and non-conformity management) andchangecontrolactivities.
- Implements processes and procedures such as vendor audits,
testing, etc., necessary tosupport productportfolios.
- Works with a broad range of internal functional groups
including Operations, R&D, Project Management, and Product
- Works closely with internal groups and outside agencies, as
required, to assure compliance with regulations as part of the
development and commercialization of the Company's intended
clinical diagnosticproducts. Works with regulators related to
product quality matters, as identified.
- Serves as a key focal point and participant in audits by
external certifying bodies and/or regulatoryagencies. Directs
and/or participates in vendor audits to assure conformity to stated
product developmentprocesses. Provides oversight for product
non-conformance situations and assure adequate investigation,
correction action and close out actions implemented.
- Drivesbest practices and tools to improve execution and
quality.Drives a culture of efficiency and accountability.
- Providesprojectanddepartmentupdatestothe executive team and
advises senior management on action plans related to product
- BS degree or equivalent, preferably in a Quality, Regulatory,
Engineering or scientific/technical area. A minimum of 8-10 years
progressive Quality, Regulatory Affairs, and technical
- IVD and molecular diagnostics experience required; Point of
care (POC) regulated device experience.
- A proven track record of having built and managed Quality and
- Product labeling expertise.
gate process for developmentandlaunchofcommercialproducts.
- Experience in CAPA and implementing quality and business
processes improvement required.
- Must be able to provide sound quality direction to set strategy
and solve problems.
- Proven structured thinking to accurately evaluate and assess
processes and problems, identify and articulate possible solutions
and drive to resolution.
assureawell-developedQualitySystemandparticipation in audits
- Preferred candidates will have experience working as a lead in
Regulatory Affairs across two or more major geographic
- Prior experience with IVD assay registration processes
Communication & Interpersonal Skills:
- Excellent verbal and written skills; able to analyze, define
and effectively convey difficult and complex issues in a way that
accurately and persuasively communicates the issues to internal and
- Skilled in conflict resolution/negotiation. Fosters open
communication. Listens and facilitates discussion.
- Strong negotiating skills and ability to think creatively and
develop creative solutions.
- Proven ability to build trust and respect within the
- Ability to prioritize and handle multiple projects.
- Interacts with external business partners and Regulatory
This role will be based in either Chicago, IL or Redwood City, CA.
Target compensation range for a Bay-area California hire is between
$240-$275k, commensurate with overall experience. Meeting minimum
requirements does not guarantee the highest end of the range.
Some remote/hybrid work may be permitted.
Keywords: Talis Biomedical, Redwood City , Sr. Director, Quality (Medical Device/IVD), Healthcare , Redwood City, California
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