Qa Director

Traditionally the role and function of the quality assurance director fell on the shoulders of Engineering Manager-type roles. The Quality assurance directors typically plan, organize, direct, control and evaluate the activities related to quality and/or engineering department, service or firm.

They are employed by a wide range of private sector and government establishments and by consulting engineering and scientific research companies.

Engineering managers with diverse backgrounds and training, are familiar with and perform some or all of the following duties:

  • Plan, organize, direct, control and evaluate the activities and operations related to quality control and assurance
  • Develop and implement policies, standards and procedures for the engineering and technical work performed in the department, service, laboratory or firm
  • Consult and negotiate with clients to prepare specifications, explain proposals and present engineering reports and findings
  • Assign, co-ordinate and review the technical work of the department or project teams
  • Recruit personnel and oversee development and maintenance of staff competence in required areas
  • May participate directly in the design, development and inspection of technical projects or in the engineering work of the department.

The  Quality  Assurance  managerial function entitled typically as Director  of  Quality  Assurance  can be held responsible for a vast array of quality-related issues, processes, operations, improvement projects and initiatives, results and outcome. Tasks and duties include responsibility for safety, compliance  and  quality  of  all processes and outcomes/manufactured  products.    The  director  QA may also be responsible  for  developing  communications,  education  and  training  to  instill  a  compliance  perspective  in  every  employees  activities, establishes  relationships  and  processes  for  building  quality  into  the  products  through  interactions  with  Research  and  Development,  Package  Engineering  and  Operations, develops  processes  and  oversees  the  review  of  data  from  physical,  chemical,  and  microbiological  testing  of  finished  product  and  components,  stability  testing,  in-process  testing,  quality  inspections,  and  release  of  raw  materials,  labels,  packaging  components,  and  finished  product for example, establishes  processes  to  review  and  approve  procedures,  validation  protocols,  validation  results,  and  specifications  as  required  assuring  compliance  and  product  quality  standards  are  in  place  by  the  time  of  product  validation, establishes  and  operates  change  control  systems  to  assure  compliance  for  the  facility,  equipment,  processes  and  acceptance  limits.    

The  Director  QA must  be  a  strong  advocate  of  compliance,  a  good  trainer  and  leader,  and  an  accomplished  manager  of  technical  resources  with  a  proven  record  in  building  and  motivating  successful  Quality  Assurance  efforts.    An  in-depth  knowledge  of  regulatory  requirements  and  their  interpretation  such  as  current  Good  Manufacturing  Practices,  Good  Laboratory  Practices,  Stability  Guidelines,  validation,  cleaning  validation,  facilities,  equipment  and  other  requirements  as  they  relate  to  the  production  of  pharmaceutical  products,  is  required.    Must  have  expert  knowledge  of  development,  production  and  control  systems,  have  training,  education  and  experience  in  Quality  Assurance.    Must  possess  sound  reasoning  ability,  analytical,  and  creative  skills  to  investigate  systems  problems  in  order  to  recommend  and  implement  solutions.

A bachelor’s degree in engineering or a college diploma in engineering technology and/or certification as a quality assurance professional is required. Extensive experience in an engineering discipline, including supervisory experience, is required. Registration as a Professional Engineer (P. Eng.) by a provincial or territorial association of professional engineers or certification as an engineering technologist (CET) is usually required. Mobility to other technical managerial positions or to research or senior management positions is possible with experience.

The  Director  QA must also have  a  working  technical  knowledge  of systems,  statistics,  auditing  and  quality  improvement  processes. At least a Bachelors  degree  or  higher  in  a  scientific/technical  area  of  study  with  a couple of years  demonstrable and successful experience  in  the  Quality  Assurance  field.  Also recommended is an advanced  degree  in  a  technical  area  (chemistry,  biology,  engineering,  mathematics  or  statistics,  pharmaceutical  sciences)  an  M.S. or  a  Ph.D.  degree  and  at  least  12  years  experience would  be  considered minimum  requirements for some positions.

The Director QA must  also  possess  good  managerial  skills  in  areas  such  as  personnel  motivation,  planning,  finance,  goal  setting  and  problem  solving, be  flexible,  willing  to  travel  and  able  to  accommodate  the  rigorous  schedule  needed  for  a  QA  organization  that  supports  a  24/7  manufacturing  operation from time to time.

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