Quality Assurance Manager
4 weeks ago
JOB DESCRIPTION – QA Manager, System Compliance
Scope of Function:
Responsible for leading the development, implementation, and maintenance of Quality Systems in support of combination drug products to include, but not limited to: Policies and Procedures, Deviations, CAPA’s, Document and Change Controls, Validation, Internal Auditing, Supplier and Material Management, and Training.
Reports to:
Sr. Director, Head of Quality
Specific Duties:
revise, edit and format Standard Operating Procedures, Logbooks, Specifications, Batch Records and other documentation according to written procedures.
storage of Master Files and executed documents in accordance with internal procedures.
Quality Systems Policies to reflect industry best practices. Identify procedural gaps/improvements for transition to commercial testing and manufacturing. Work in tandem with subject matter experts to address gaps.
Facilitate in the investigation of customer complaints and/or internal non-conformances.
the Quality Systems readiness for regulatory and customer inspections.
investigate and close Incident reports, Deviations, Investigations, Change Controls and CAPAs.
QA review and approval all equipment master records, IQ/OQ/PQ, transfer forms, status change forms, calibration and preventive maintenance records.
QMS routine meetings such as Deviation and change control.
Participate as needed in client audits as well as regulatory audits.
record and Label generation and reconciliation.
Room/Equipment Compliance and clearance activities as needed. .
Annual Updates of DMF to FDA.
Responsible for maintenance of the Supplier Management program.
Reviews all Policies and Procedures for the Division.
Develops, maintains and monitors Metrics for the Quality Department.
Responsible for the adequacy and improvement of the training program.
Ensures that all products are manufactured in compliance with 21 CFR 211 or other applicable regulations.
Education and Experience Required:
Bachelor's degree in Life Sciences or a related scientific field
Minimum of seven years’ experience working in an FDA regulated environment in Biologics, Pharmaceuticals, Medical Devices, or Tissue.
Minimum one year working with Electronic Quality Management Systems such as Master Control, Documentum, Qualio, or Trackwise
Skills:
Proficiency with technical writing and written and verbal communication.
Interacts with:
All TBI employees, clients, consultants, and global regulatory agencies.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
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