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Site Quality Risk Manager Job

Date: Oct 26, 2017

Location: Carlow, IE

Company: MSD

Requisition ID: QUA006054

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

MSD Carlow is a site leader, manufacturing biologic products under aseptic conditions for vials and vaccines which are distributed across the globe.

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 MSD'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 at MSD 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. At MSD, we’re inventing for life. 

If you need an accommodation for the application process please email us at staffingaadar@MSD.com.



Job: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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