Position

DIRECTOR OF Quality Assurance

Pharmaceutical & Medical Device

 

Full-time
Santa Rosa, California

DESCRIPTION

  • Lead a QA team to develop, direct and maintain a cGMP compliant quality system throughout the company.
  • Effectively analyze, develop and implement systems, processes and equipment in compliance with ISO and FDA requirements.
  • Direct internal and external audits.
  • Develop and implement quality control process sampling systems, procedures, and statistical techniques. 
  • Maintain and direct all cGMP/ISO Quality Assurance related requirements and responsibilities. 
  • Support the CAPA process, collaborate with owners to ensure effective root cause analysis and the development of innovative, long-term solutions. 
  • Maintain metrics for quality systems including supplier quality, non-conformances, and CAPA. 
  • Tracks the effectiveness of corrective action plans and compliance improvement initiatives. 
  • Responsible to review and establish quality goals within the company on an annual basis.
  • Experience with Design Control (i.e. Design input/output),
  • Experience in leading new validation activities for processes, products and engineering.
  • Experience in the development of a design master file, FMECA and PFMECA
  • Experience with test method validations.
  • Experience working across different department teams such as: QA, QC, Regulatory, Manufacturing, Inventory, Marketing.

 

EDUCATION REQUIREMENTS:  

  • Minimum of B.S. in life sciences, engineering, or equivalent required. 
  •  Advanced degree preferred.  

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EXPERIENCE REQUIREMENTS: 

  • Minimum 7-10 years of experience in Quality Assurance for pharmaceutical and medical device biopharmaceutical companies. 
  • Experience with successful FDA and international agency negotiations and audits. 
  • Excellent verbal and written communication skills. 

  

OTHER QUALIFICATIONS: 

  • Detail oriented with well-developed organizational and analytical skills. 
  • Suited to working in a fast-paced, small company environment. 

 


WE VALUE INNOVATION, SCIENTIFIC RIGOR, COLLABORATION AND A PASSION FOR CHANGE.