Clinical QA Manager

Company: Confidential
Location: Austin
Posted on: May 14, 2022

Job Description:

Clinical QA Associate

Company:
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 placental-based allografts.
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.

Position :
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 requirements.
Maintain the SOPs/Policies/Work Instruction (WI) Spreadsheet until eQMS is established.
Maintain Clinical Development Glossary as it relates to Policies and SOPs.
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 documents).
Assist the Executive Director, CQA with establishing annual training for Clinical Development.
Facilitates and assists in the development of Corrective and Preventative Plans.
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 activities.
Perform Vendor, Investigator Site, PV, and document audits upon request.
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.
Qualifications:
- 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 preferred
- Strong understanding of clinical development processes as they relate cross-functionally
- Experience writing SOPs (ideal if you have written Work Instructions, Forms/Templates)
- 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 Development.
- Understanding of quality risk management and quality by design principles.
- Experience conducting GCP audits (including internal PV audits)
- Demonstrates skills in problem solving, works independently and in a team environment
- Ability to multi-task and manage conflicting/changing priorities

Keywords: Confidential, Austin , Clinical QA Manager, Healthcare , Austin, Texas