BrightOwl Loader Loading

QA Manager - Ireland  

Company managed [?] Still accepting applications

Posted on : 26 April 2017

Project Description


BASIC SUMMARY:
  • Responsible for managing the Quality Assurance program component at a company operation.  
  • Assists Regulatory Affairs and Compliance management in implementing the  company Compliance Program. 
  • Works with the site management team to assure regulatory compliance and consistency with company  policies and procedures.


ESSENTIAL DUTIES AND RESPONSIBILITIES:  
  •   Communicate all identified compliance and quality risks to his/her supervisor.
  •   Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled.
  •   Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
  •   Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities.
  •   Schedule resources to manage compliance systems and assure timely completion of: 
    •  audits of regulatory records and reports; 
    •  inspections of facilities and equipment;
    • investigations,
    •  audits of methods, practices, and controls.
  •   Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
  •   Assure that all records and reports are prepared, communicated, and retained in accordance with applicable regulatory requirements.
  •   Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management. 
  •   Represent the corporation during regulatory and client inspections/audits.  
  •   Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
  •   Track corrective actions and apprise management of their status.
  •   Assure vendors and suppliers identified/designated by company are assessed for the compliance with applicable regulatory requirements.
  •   Participate in Regulatory Affairs and Compliance projects and programs.
  •   Assure that Corporate Quality and Compliance Policies are implemented and administered at the site/operation.
  •   Manage activities of assigned group(s) to ensure optimum performance of the group/function.
  •   Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
  •   Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
  •   Assist in the development and recommendation of departmental budget and authorize expenditures.
  •   Develop and oversee the implementation of departmental training programs, including orientation.
  •   Support the policy of equal employment opportunity through affirmative action in personnel actions.
  •   Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  •   Performs all other related duties as assigned


Qualifications
Education:  Bachelor’s degree (B.A./B.S.) or equivalent 



Experience: 
  • Minimum of five (5) years experience in the pharmaceutical and/or biotechnology based industry. 
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Experience in supervision quality assurance, quality control, and/or regulatory affairs.
  • Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies.
  • Good working knowledge of pertinent regulations and site SOPs.
  • Demonstrates strong leadership ability, communication, and facilitation skills.