Clinical QA Manager
Posted on: May 14, 2022
Clinical QA Associate
At Confidential, we are committed to making a difference in the
lives of patients through regenerative medical therapy. We value
dedication, innovation, timeliness, and integrity. By creating an
inclusive and engaging environment, we encourage our colleagues to
live to their highest potential. We also offer a wide variety of
competitive benefits for our employees.
Discover the newest generation of naturally bioactive products for
regenerative therapies. Direct Biologics offers a platform of
regenerative products, including extracellular vesicles and
Confidential is a market leading innovator and cGMP manufacturer of
regenerative biologic products, including ExoFlo---, a COVID-19
therapeutic geared solution, that leverages the regenerative
properties of bone marrow mesenchymal stem cell (MSC)-derived
extracellular vesicles. ExoFlo--- is currently used for
investigational treatment of COVID-19 associated moderate-to-severe
ARDS in an FDA approved clinical trial as well as an FDA approved
Expanded Access Protocol for hospitals.
Coordinates and authors the development, review, comment management
and approval of GCP related policies and procedures.
Assures that procedural documents have the appropriate SME review
and do not conflict with other procedures or overall GCP
Maintain the SOPs/Policies/Work Instruction (WI) Spreadsheet until
eQMS is established.
Maintain Clinical Development Glossary as it relates to Policies
Coordinate Training on SOPs/Policies/Work Instructions (WIs) as
related to Clinical Development.
Tracks and develops training compliance reports based on internal
requirements (e.g. Read and Understand of procedural
Assist the Executive Director, CQA with establishing annual
training for Clinical Development.
Facilitates and assists in the development of Corrective and
Provide CQA oversight and auditing of eTMFs
Assist the Executive Director, CQA with the management and
coordination of BIMO sponsor inspections, and other regulatory
agency sponsor inspections of offices in relation to GCP
Perform Vendor, Investigator Site, PV, and document audits upon
Perform Internal Audits as SOPs and WIs are established.
Create Quality Audit Plans for each clinical trial study / program
and ensure they are implemented and executed.
- 3 - 6 years pharma experience (minimum of 4 years in a GCP
environment working in a Clinical Compliance group)
- Bachelor's Degree in a life-science
- Up to 25% travel
- Demonstrates competency in the design/development of SOPs,
supporting documents and performance support tools
Experience using Electronic Document Management Systems is
- Strong understanding of clinical development processes as they
- Experience writing SOPs (ideal if you have written Work
- Experience in metrics design, risk assessments and evaluations to
provide program/study level quality oversight.
- Excellent communication skills and ability to work with people in
all levels of the organization and externally.
- Excellent project management and organizational skills.
- Excellent teamwork and leadership skills, including conflict
resolution expertise and discretion.
- Ability to deal with cross-functional teams from Clinical
- Understanding of quality risk management and quality by design
- Experience conducting GCP audits (including internal PV
- Demonstrates skills in problem solving, works independently and
in a team environment
- Ability to multi-task and manage conflicting/changing
Keywords: Confidential, Austin , Clinical QA Manager, Healthcare , Austin, Texas
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