MANAGER, QUALITY ASSURANCE

Location
Durham, NC
Posted
Sep 15, 2018
Institution Type
Four-Year Institution

diversity employer



MANAGER, QUALITY ASSURANCE
Regulatory

Quality Assurance (QA) is responsible for ensuring that components,
intermediates, drug
substance, and drug product
are of the quality required for their intended use and that quality
systems are maintained. The QA
Manager will perform a
variety of duties associated with the Quality System Unit (QSU) in
support of the GMP programs at
Duke University,
including release of products/clinical trial material, assistance with
deviation and event
management, review of vendor
qualifications, and oversight of component control and disposition. The
QA Manager will function
as central point of
contact and serve as a daily liaison for strategic issue resolution and
oversight of major cGMP
quality systems, including
training, validations, and equipment management. This position will
consult with manufacturing
operations staff, as
applicable/requested, to serve as a resource. This position reports to
the Director of Regulatory
Affairs and Quality.

Requisition Number
401443506

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2765 MANAGER, QUALITY ASSURANCE

Job Family Level
86

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer
committed to providing employment opportunity without regard to an
individual's age, color, disability, gender, gender expression, gender
identity, genetic information, national origin, race, religion, sex,
sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation,
creativity, and belonging. Our collective success depends on the robust
exchange of ideas—an exchange that is best when the rich diversity of
our perspectives, backgrounds, and experiences flourishes. To achieve
this exchange, it is essential that all members of the community feel
secure and welcome, that the contributions of all individuals are
respected, and that all voices are heard. All members of our community
have a responsibility to uphold these values.

Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may
include essential job functions that require specific physical and/or
mental abilities. Additional information and provision for requests for
reasonable accommodation will be provided by each hiring department.


Education

Required: Bachelor of Science or Bachelor of Arts degree
Preferred: Master's degree or PhD
Preferred: Certified Quality Auditor and/or RAC Certified


Experience

Required:
Minimum 5 years of experience in a GxP regulated environment.
Leading projects and teams with measurable deliverable outcomes
Experience in representing the QA Department at upper level management
meetings and/or outside of the organization.
Making QA decisions independently.
Experience in representing department in audits and inspections.
Managing team related projects.
Experience in monitoring the overall effectiveness of the in place
quality systems and gap analysis.

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR
EXPERIENCE

Auto req ID

102194BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI104409854

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