Quality Assurance Manager

Location
San Diego, CA
Posted
Jul 11, 2018
Required Education
Bachelors Degree
Position Type
Full time

MEI Pharma (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective oral PI3K delta inhibitor being developed for B-cell malignancies, and ME-344, a novel mitochondrial inhibitor.  MEI currently has an open position in our Regulatory Affairs Department for:

Quality Assurance Manager

 

Position Summary:

Reporting directly to the Associate Director of Quality Assurance, the Quality Assurance Manager is responsible for maintaining and execution of systems and processes to ensure compliance with cGMP regulations. The role is responsible for providing quality guidance and working with MEI internal departments to meet company goals and objectives.  Key functions are in the areas of Document Control, Records Management, Internal Audits, Training and Batch Review/Release. 

Responsibilities:

  • Tracks, monitors and processes MEI Change Requests in compliance with established procedures.
  • Manages cGMP records including records associated with: change history, vendor evaluation, audits, quality agreements, batch history, training, label approval, master copies and other records generated to comply with MEI quality requirements.
  • Works with internal departments to support the development of standard operating procedures, controlled forms, and product/labeling/packaging specifications for use in daily operations.
  • Manages the internal audit program including scheduling and performing internal audits.  Evaluates adequacy and effectiveness of corrective action plans.
  • Administers and evaluates the effectiveness of SOP Training.
  • Performs batch review and product dispositions.
  • Assists with preparation for regulatory inspections.  Provides documentation support during inspections.
  • Tracks, monitors and ensures compliance with key quality systems – Training, Complaints, Investigations, Exception reporting, Label approval and SOP review.
  • Performs or facilitates the performance of GXP Training.
  • Follows applicable regulations, including FDA, ICH, GXP, and MEI policies and procedures.
  • Other QA activities may be performed as required.

 

 

Requirements:

  • Bachelor’s degree in a scientific/technical discipline with 7+ years’ pharmaceutical experience, or an equivalent combination of education and experience with expertise in the following:  
  • Pertinent federal and state laws related to pharmaceutical industry.
  • Current FDA, EMA and federal regulations and guidance concerning the conduct of clinical research including Good Clinical Practice (GCP), desirable. 
  • Experience in Commercial Pharmaceutical QA systems a plus. 
  • Experience with Business, scientific and personal computer hardware and software applications (MS Word, Excel, Access, Outlook, Adobe Acrobat) as well as with Electronic Data Management Systems and their implementation, desirable.
  • High level of professionalism and collaboration in team settings.
  • Ability to manage tasks with competing priorities or deadlines.
  • Successful experience in fast-paced entrepreneurial environment
  • This is an office-based San Diego position with a potential for some travel as needed.
  • There is no relocation benefit.

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking)
  • Ability to lift office supplies/files
  • Routine office duties including computer keyboard use
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate.