Manager, Quality Assurance

Subsidiary:

QED Therapeutics

Reports to:

Associate Director, Quality Assurance

FLSA Status:

Exempt

Position Summary

Reporting to the Associate Director of Quality Assurance, the Manager of Quality Assurance assists in the quality oversight of GxP activities internally and externally with QED vendors and service providers including, but not limited to, external document review and approval, batch disposition, commercial launch, and production. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.

Job Responsibilities:

Provide oversight of GMP Quality Assurance activities at QED, including:

  • Quality oversight and management of GMP clinical or commercial drug substance and drug product manufacturing and testing at CMOs
  • Work closely with CMC and CMOs to aid in the transfer and execution of manufacturing and method transfer including validation activities
  • Review of CMO executed batch records, test results including stability and quality system oversite (Investigations, Product Complaints, CAPA and Change Control)
  • Batch disposition activities for both clinical and commercial drug substance, drug product batches, and clinical trial packs
  • Quality oversight of stability transfer and stability program
  • Participate in management of GMP activities associated with commercial launch
  • Internal change management
  • Internal and external GXP audit support
  • Assist in management of GMP quality events
  • Participate in pre-approval inspection readiness activities for GMP activities at QED and CMOs.
  • Participate in QED CMO pre-approval inspections
  • Assist in the implementation and maintenance of QA GMP standard operating procedures (SOPs) and associated controlled documents
  • Perform trainings on GxP topics and QA policies/procedures, and other required topics
  • Assist in Computer System Validation activities
  • Support the management of Quality Assurance Agreements
  • Participate in the generation and compiling of metrics reports to support Quality Management Review
  • Provide support to senior QA management as needed

Competencies:

  • Excellent verbal and written communication skills
  • Ability to effectively communicate sound quality advice cross-functionally, based on regulations and business needs
  • Demonstrated ability to apply knowledge strategically and operationally across projects within a matrix environment
  • Strong organization skills with the ability to effectively multi-task and prioritize
  • Ability to easily adapt to changing priorities and business needs, and meet timelines within a fast-paced environment
  • Detail oriented, self-motivated and ability to display sound judgement and problem-solving skills

Required Qualifications

  • Bachelor’s degree in a scientific discipline, preferably Biology or Chemistry
  • Minimum of 5 years pharmaceutical industry experience including Quality Assurance or Quality Control
  • Understanding of applicable regulations such as 21CFR Part 11, 210, and 211; ICH Q1 – Q10 and E6

Contact:

If you qualify for this position and are interested, please send resume and cover letter to info@qedtx.com

careers

Manager, Quality Assurance