QC DIRECTOR - BIOTECHNOLOGY

 

 

QC Director Biotechnology

 The QC Director oversees all of the quality activities in support of product production and releases.  The position has interaction with all other internal departments, including Production,  Cell Culture, Facilities, Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position has and/or supervises interaction with external entities including contractors and suppliers. The QC Director ensures and guides the performance of a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, as needed, overseeing the coordination of testing schedules, trending, and reporting results.

 KEY RESPONSIBILITIES

· Ensures that all routine testing and cell bank testing is performed to meet business needs and is in accordance with quality requirements.

· Manage and develop QC staff.

· Prepare and maintain budget, using appropriate resourcing.

· Ensure that projects are appropriately supported by Quality Control, and develop creative strategies and resourcing with regard meeting the project timelines.

· Benchmark data to identify opportunity for continuous quality improvement and guide strategy to implement.

· Set strategy for implementation of novel technology practices in Quality Control testing.

·  Set strategy to meet corporate and departmental objectives and track performance against objectives.

· Perform as Project Leader to further corporate objectives.

TECHNOLOGY COMPETENCIES

Technical and Scientific Proficiency

Ability to solve complex problems to attain crucial project goals.  Define initiatives to be pursued.  Champion policies and processes that incorporate innovative trends and practices in the field of Quality.

 

Data Analysis Requirements

 

Proficiency in the use of various statistical tools. Establishes value added metrics and assures reporting and compliance.

 


Regulatory Requirements

Applies and interprets current laws and industry trends and ensures implementation within organization.  Develops and/or drives the organization’s Quality Control system.

 

Systems Requirements

Interpret current laws and industry trends against organization capabilities and efficiencies.  Ensure the systems and processes of the organization support the mission.  Applies expertise to shape organizational strategy and direction.

 

DOCUMENT CONTROL COMPETENCIES

 

Regulatory Requirements 

 

Recognized as an expert by colleagues and influences requirements through expertise.

 

Systems Requirements 

Shapes the organization through identification of system structures for documentation.  Assures changing regulatory requirements are implemented and impact on documentation is addressed.

 

Processes/Procedures Compliance Requirements

 

Identifies, develops and manages continuous improvement activities.

 

PREFERRED EDUCATION AND EXPERIENCE

Requires a Bachelor’s Degree or equivalent, with 12+ years of experience in a GMP/GLP regulated environment.  Microbiology, histology, chemistry, and/or cell culture experience required.