Quality Assurance Site QRM Lead - Ireland
Want to know company name or location? Company managed [?]
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Quality Assurance Site QRM Lead
The Site QRM Leader is a new position that will be responsible for leading compliance improvement opportunities across the 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 company'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
- Bachelors Degree or higher preferred; ideally in a related Science discipline, Engineering or other Technical Discipline.
- Six Sigma qualification preferred
- 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 site.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Job Segment: Engineer, Risk Management, Supply, Quality Assurance, Fundraising, Engineering, Finance, Operations, Technology, Nonprofit