Duke University Job Descriptions
Duke Job Postings
To see if there are current openings for any of the job descriptions listed on this web site, please search Duke Jobs.
ASSOCIATE DIRECTOR, QUALITY CONTROL
Job Title: ASSOCIATE DIRECTOR, QUALITY CONTROL
Job Code: 2462
FLSA:
Job Level: 73
Revised Date: 02/01/2022
Job Family: JF 05
Occupational Summary
The Associate Director, Quality Control will lead development activities, qualification and execution of analytical methods to enable release of cellular products for administration.. Additionally, the Associate Director, Quality Control is responsible for planning, organizing, and overseeing the day to day activities related to cGMP production testing. This incumbent in this position will be involved in all aspects of specialized testing of cellular products for clinical trials and commercial operations, supporting GMP production of cellular products and therapeutics
The Associate Director, Quality Control will support the development, qualification and execution of analytical methods to enable release of cellular products. This incumbent in this position will be involved with specialized testing of cellular products for clinical trials and commercial operations, supporting GMP production of cellular products and therapeutics. In addition, this individual will be responsible for environmental monitoring of the GMP facility, and projects manufactured therein, to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical and commercial material for novel cellular therapies.
Work Performed
In conjunction with ORAQ leadership but functioning independently:
Create and maintain a robust quality control characterization and testing program, within a robust quality system, for various cellular therapies with products in varying stages of development.
Lead pharmaceutical development and successful GMP release including:
Analytical development, product specific release and characterization methods
Qualify methods for product release and complete comprehensive characterization of clinical lots.
Complete GMP testing in line with ICH and regulatory guidance.
Lead and coordinate qualification testing of cellular therapy products, including tech transfer and associated testing under GMP conditions.
Execute and document development and GMP activities in compliance with regulatory requirements.
Leads collaboration with other development teams to provide support for development activities and will work diligently with cell line development and analytical development functions to understand how the process impacts product quality.
Analyze and interpret data and results of individual and team work, utilizing the data in appropriate decision making; summarize data and present results.
Authoring and managing oversight of QC deviations, non-conformances, CAPAs, out of specifications, complaints, and all associated required reporting.
Lead writing and review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
Manages and optimizes strategies for efficient review, editing and approval of documentation, reports, SOPs.
Identifies and documents innovations including patenting and publishing of scientific results.
Supervise, coordinate and lead the work of Quality Control staff and provide feedback, as appropriate.
Mentor and develop junior staff.
Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
Communicate clearly, both verbally and in writing, regarding staff assignments, time off for staff, management reporting, resource requirements and utilization, problems and prospective solutions.
Organizes and leads group meetings and larger team settings.
Liaise between Duke facilities and external entities, including regulatory agencies and external sponsors or vendors.
Oversee shipping, preparation and coordination of product testing with outside vendors.
Engage external vendors for coordination of quality control testing.
Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
Manage data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarizing data and present results for senior management.
Authors reports for use by institute and ORAQ leadership.
Manages routine environmental monitoring of the GMP Facility to ensure facility remains in state of microbial control.
Manages and coordinates Quality Control activities in a cleanroom environment while following associated GMP and regulatory guidelines.
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.
Required Qualifications at this Level
Education/Training
Required: Bachelor of Science or Bachelor of Arts degree Preferred: Masters degree or PhD
Experience
Required: Minimum 5 years of experience in a GxP regulated environment. Leading projects and teams with measurable deliverable outcomes Experience in representing the QC Department at upper level management meetings and/or outside of the organization. Making QC 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.
Preferred: None
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
Required:
Experience in development of analytical methods Demonstrates innovation in development of diverse analytical methods (product characterization and GMP product release testing, including but not limited to, flow cytometry, biochemical methods, endotoxin, and sterility) is required. GMP experience is preferred. Must work independently to develop specific processes or methods in line with strategic program goals. Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans. Strong oral and written communication skills Leading projects and teams with measurable deliverable outcomes. Experience in representing the QC team at upper level management meetings and/or outside of the organization. Making QC decisions independently. Experience in representing department in audits and inspections. Experience with environmental monitoring in a GMP environment. Managing team related projects. Experience in monitoring the overall effectiveness of the in place systems and performing gap analysis. Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.
Special competencies/credentials: Required: None
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job- related tasks other than those specifically presented in this description
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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.
