MANAGER, QUALITY ASSURANCE - GXP

Location
Durham, NC
Posted
Jan 10, 2018
Institution Type
Four-Year Institution

diversity employer



MANAGER, QUALITY ASSURANCE - GXP
Regulatory

Primary role:

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.

Essential tasks/responsibilities:

In conjunction with the QA Director:
  • Create and maintain a robust quality management program for various programs with products in varying stages of development.
  • Manage QA team, activities, projects, occurring in the department.
  • Oversight of program(s) for tracking deviations, non-conformances, adverse events, complaints, and all required reporting to regulatory bodies.
  • Represent the QA Department at Upper Management meetings.
  • Collaborate with end users about quality related issues and implement actions.
  • Communicate clearly, both verbally and in writing, regarding staff assignments, quality reporting, resource requirements and utilization, problems and prospective solutions.
  • Support Right First Time (RFT) initiatives and help develop programs that encourage operational efficiency between the Quality Department and Operational Staff.
  • Analyze reports, graphs, spreadsheets, and other data that integrate the information contained to facilitate departmental and individual performance.
  • Actively participate in and lead the design and implementation of processes.
  • Independently audit on behalf of the department/organization serving as Lead Auditor.
  • Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
  • Serve as back up for Assistant QA Director/QA Director.
  • Ensure key performance indicators (KPIs) are consistently met and team members achieve their potential

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.




Requisition Number
401369052

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

Skills:

Required:
• Expert knowledge of GxP
• Must possess strong communicating skills with the ability to communicate effectively at all levels of the organization
• Demonstrates comprehensive decision making skill by taking independent and timely decisions; communicates, influences and escalates issues, and serves as final authority, as appropriate.
• Strong partnering and negotiating with multiple internal, and frequently also external stakeholders.
• In conjunction with the Director, be a leader with a clear understanding of regulatory expectations.
• Ability to hire, develop and retain top talent for the QA department.
• Capability of leading multiple projects within multidisciplinary environments.
Preferred:
• Team player with sense of urgency to carry out tasks in a timely and accurate manner.
• Possess an acute attention to detail and be exceedingly good at multitasking.
• Ability to interact well with employees at all levels.
• Strong organizational skills.
• Excellent verbal, written, and interpersonal skills.
• Possess good problem-solving skills.
• Adapt to changing priorities effectively.
• Ability to work independently on assignments.


Auto req ID

96560BR

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.

PI100798431

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