Senior Quality Assurance Manager

2 weeks ago

Rockville, United States Kolon TissueGene, Inc. Full time

Job purpose

 

The QA Manager/Senior Manager will be responsible for the leadership and oversight of the Quality Systems at KTG. This individual will be required to provide subject matter expertise support across both GMP and GCP organizations. This position will foster Quality actions that encourage a culture resulting in behaviors, mindsets, actions, and processes that provide value and alignment with International Regulations.

 

Duties and responsibilities

 

Under the direction of the Senior Director, Quality Assurance or designee, the QA Manager/Senior Manager:

 

  • Works closely with Manufacturing regarding product quality planning, design and improvements to ensure Quality is built into manufacturing processes.
  • Supports Internal audits and external vendor audits including leading audits and providing the required reports and documentation.
  • Performs change control assessments to Quality Systems including document management, change control and CAPA.
  • Approves Deviations and CAPAs and ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address the root cause.
  • Acts as Quality Subject Matter expert and represents Quality in internal and vendor meetings.
  • Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
  • Manages the QA review of Batch Records
  • Manages SOP review process and assists in identifying gaps.
  • Communicates changes in regulations and practices to the organization effectively and in a timely manner and aids in the development of plans to address these changes.
  • Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements.
  • Other Duties as assigned.

 

Qualifications

  •  A minimum of a bachelor's degree in a scientific discipline.
  • A minimum of 5 years of Quality Assurance Experience.
  • A minimum of 3 years of experience in a Quality Assurance management role
  • A minimum of 3 years of audit management experience preferably in Manufacturing.
  • A minimum of 3 years of CAPA and Change Management experience.
  • Demonstrated mastery/understanding of Quality Systems and Quality controls.
  • Detailed working knowledge of cGxP requirements and current FDA regulations.
  • Experience in the preparation of IND and BLA applications.
  • Strong interpersonal skills: team building, consensus building, and conflict resolution
  • Well-organized and detail-oriented with strong verbal and written communication skills.

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