Asst Director, Quality - WFIRM | WF Institute for Regen Medicin

Wake Forest Baptist Health
Job Title: Asst Director, Quality - WFIRM
Job ID: 5385
Full/Part Time: Full-Time
Regular/Temporary: Regular
Job Category: Professional / Management
Winston-Salem, NCProfessional / Management, Medical, Healthcare12/18/2013Regenerative MedicineFull-time regular, 40 hours/week Job Summary:Head of the quality program within the RMCC. Will set strategic direction for the RMCC''''s quality systems in the areas of Quality standards, SOPs, ensuring the integrity, consistency, internal and external compliance. This...

Job Description


Regenerative Medicine

Full-time regular, 40 hours/week

Job Summary:

Head of the quality program within the RMCC. Will set strategic direction for the RMCC's quality systems in the areas of Quality standards, SOPs, ensuring the integrity, consistency, internal and external compliance. This role will also ensure appropriate metrics are defined and measured, enable monitoring of regulations to ensure continuous improvement of the process.

Will manage processes to meet all applicable regulatory requirements; ensure harmonized and efficient processes to assure sustainability of the Quality Systems; ensure processes remain current with regulatory requirements; establish and train on applicable processes and procedures; monitor compliance and effectiveness through trending, analysis, metrics, and reporting to senior management; monitor Key Performance Indicators and identify opportunities for continuous improvement.

The selected candidate must be able to develop and implement simple, yet effective quality processes and metrics. As such, experience with Quality systems is necessary. This individual must be able to evaluate quality processes and drive continuous improvements, not only to meet minimum regulatory requirements but also to enable fostering excellence in quality, experience with documentation and technical writing, in a regulated compliance environment.

Job Summary:
The Assistant Director, Quality is the head of the quality program within the RMCC. The assistant director will set strategic direction for the RMCC?s quality systems in the areas of Quality standards, SOPs, ensuring the integrity, consistency, internal and external compliance. This role will also ensure appropriate metrics are defined and measured, enable monitoring of regulations to ensure continuous improvement of the process. The Assistant Director, Quality will manage processes to meet all applicable regulatory requirements; ensure harmonized and efficient processes to assure sustainability of the Quality Systems; ensure processes remain current with regulatory requirements; establish and train on applicable processes and procedures; monitor compliance and effectiveness through trending, analysis, metrics, and reporting to senior management; monitor Key Performance Indicators and identify opportunities for continuous improvement.

Education / Experience:
Master's degree in an appropriate scientific discipline or MBA and six years of related quality experience; or, graduation from a four-year college or university with a major in life sciences or biology, chemistry or other science related discipline and 8 years of related quality experience.

Reports To: Associate Director, Translational Research

Licensure, Certification and / or Registration:

Essential Functions:

1. Oversees and directs the development of quality systems and activities.
2. Responsible for developing and maintaining; and assures appropriate compliance to GMP, GTP, GCP, GLP and GDP requirements.
3. Responsible for assuring compliance of quality plans and policies for entire organization.
4. Directs the validation program and policies.
5. Provides oversight for the Deviation Management and Change Control programs.
6. Provides technical support and final approval for all deviations, investigations and CAPAs.
7. Provides final approval and assurance for all quality and manufacturing documentation and activities.
8. Provides guidance and input concerning implementation of new Quality Control testing and procedures.
9. Provides management and direction for the Quality Assurance program and activities.
10. Provides management and direction concerning the Document Control systems and programs.
11. Provides oversight for the development and implementation of the Training program.
12. Responsible for development of quality requirements for new products, processes and materials translating into the RMCC.
13. Responsible for updating and maintaining current laboratory standards, processes, equipment and test methods.
14. Determines certification requirements for the RMCC (ISO, AABB, etc.).
15. Responsible for RMCC Environmental Monitoring Program.
16. Provides quality input and guidance on CMC sections for regulatory submissions.
17. Writes and/or revises documentation to support quality systems, data systems, technical issues and instrumentation.
18. Trains lower level personnel on all quality functions and processes.
19. Attends internal and external seminars, training sessions and workshops to maintain competency in evolving current GMP regulations and job functional requirements.
20. Provides technical support for troubleshooting activities dealing with quality functions and processes.
21. Takes initiative to identify opportunities for process improvement and implementation.


Skills and Qualifications:

Excellent recordkeeping and documentation skills
Ability to develop and implement quality processes and metrics
Ability to evaluate quality processes and recommend improvements
Experience with documentation and technical writing in a regulated compliance environment.
Strong communication skills, both verbal and written
Understanding of Microsoft Excel, Word and other computer software
Outstanding interpersonal skills, high energy and motivated
Supervisory experience required and management experience preferred

Work Environment:
The Regenerative Medicine Clinical Center (RMCC) is constructed to enable the production of tissue engineered products for evaluation in Phase I/II clinical studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations for biological products and human cells, tissues, and cell and tissue based products.

The RMCC consists of ISO 7 and ISO 8 classified cleanroom space along with an external Quality Control Laboratory and Warehouse. Access to all classified areas requires appropriate gowning and aseptic techniques.

To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".

Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-0175. Office hours are Monday-Friday, 8:00am-5:00pm.

If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at accommodationrequest@wakehealth.edu.

It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.



Quick Reference

Human Resources
General Employment

Phone 336-716-4717
FAX 336-716-5656

Nurse Recruitment

Phone 336-716-3339
FAX 336-716-5656

nrsrecrt@wakehealth.edu

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