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Senior Manager / Director of Quality Assurance

  • Location

    San Diego

  • Sector:

    Life Sciences

  • Job type:


  • Salary:


  • Contact:

    Cortland Hotz

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    about 1 year ago

  • Expiry date:


  • Startdate:


Start working for a clinical stage biotech company in San Diego, CA. The company is developing products for the treatment of rare diseases using a combination device/drug prodct. 


The position requirements include:

·      Manage processes assocaited with Quality Systems for all generic good practice areas.

·      Manage processes assocaited with Phase-appropriate worldwide QA strategy covering cGMP/QSR's (drug and device), and GCP

·      Oversee supplier and vendor management including qualification, auditing and on-going Quality Management

·      Perform batch reviews and release of Clinical Trial Materials.

·  Construct SOP's, oversee training.

·  Experience in achieving "Inspection Readiness" for GMP and GCP areas

·      Lead QA support during internal and external audits

·      Review technical documents and agreements from QA perspective  


Candidate background and experience:

·      10 years of experience initiating and implementing Quality Systems (investigational pharmaceutical products).

·      Experience with developing phase-appropriate QA strategy that would be compliant with US and EU requirements, and successfully implementing it

·      Experience with Quality Systems relating to the development of a drug/device combination product would be highly desirable

·      Experience working in a virtual environment



Education and skills

·      BS/MS/PhD in a Science or related filed

·      Proven leadership skills 

·      Flexible in approach to overcome obstacles that meet all Quality requirements.

·      Excellent communication skills.

·      Excells in a high-paced environment typical of early stage companies.

·      Requires williness to use skills ranging from strategic thinking to hands-on drafting of quality documents.