QA Manager - Ireland
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- 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.
- 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;
- 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
- 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.