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Site Quality Risk Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Carlow
  • Sector: Scientific
  • Date posted: 26/09/2017
  • Job reference: J374629A

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Site Quality Risk Manager Job

Site QRM Leader The Site QRM Leader is a new position that will be responsible for leading compliance improvement opportunities across the Carlow site to strengthen our overall quality and compliance performance. The Site QRM Leader will report to the Site Quality Director and will be responsible for the effective management and stewardship of the site Quality Risk Management processes.

The QRM Lead will be responsible:

- For ensuring that Quality Risk Management objectives are effectively achieved, are consistent with s requirements to ensure compliance, safety and a reliable supply to our customers.

- Managing the site Quality Risk Management system and acts as a subject matter expert and resource for all QRM matters on the site

- Formulate risk management strategies and principles and documents in appropriate policies and procedures - Responsible to develop and implement the appropriate risk assessment tools used to support quality risk management activities.

- Analyses and manages the risk management process for prospective changes (e.g. for process changes & new product introductions) and for issues arising (e.g. deviations) as deemed necessary by identifying, measuring, and making decisions in conjunction with key stakeholders.

- Manages the training of site staff in quality risk management principles and practices and acts as a subject matter expert and resource for QRM matters.

- Manages and leads data driven risk assessments (risk identification, analysis and ranking).

- Oversee QRM program to ensure risk assessments are conducted as per required frequencies and manage the overall process, tasks, and communications.

- Communicate the outcome from quality risk management activities to all business partners

- Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System

- Function as a fully integrated member of the Quality Assurance management team, advising on all QRM matters.

- Represent the sites approach to Quality Risk Management during Board of Health and other GMP inspections

Qualifications Minimum Experience:

- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.

- Advanced leadership skills including ability to lead across function team and work across boundaries.

- Communication, decision making, people influencing and project management skills will be important.

- Critical to success will be an expert level of knowledge of cGMP and Quality System regulations as they pertain to all aspects of the Carlow site. Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.