Senior Specialist, External Quality Job

Date: Jan 7, 2019

Location: Carlow, IE

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Requisition ID: QUA008460


MSD Inc. 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 legacy for over a century. 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. 




This position will lead and support activities involved in the design/development, implementation, governance and sustainment of a harmonized Quality Risk Management (QRM) program including standards, business processes, tools, and training for MSD’s External Manufacturing and External Quality Assurance organizations.




Responsibilities include, but are not limited to:




  • Develop Quality Risk Mangement (QRM) expertise through completion of assigned training and tasks to serve as a Subject Matter Expert for MSD’s External Manufacturing and External Quality Assurance organizations.

  • Partner with QRM Center of Excellence and other QRM personnel to ensure that departmental business processes developed are implemented and aligned with approved QRM documents in the Quality Management System. 

  • Partner with QRM Center of Excellence and other QRM personnel to develop and deliver training on tools and businesses processes to be utilized by MSD’s External Manufacturing and External Quality Assurance organizations.

  • Provide guidance for the facilitation of QRM strategies for complex or cross-site/cross-product risk management in MSD’s External Manufacturing organization.

  • Plan, lead, and coordinate performance of Quality Risk Assessments, where required.

  • Partner with customers, key stakeholders, and management, to communicate/escalate identified risks to ensure adequate resource allocation (where required) and timely resolution.

  • Sub-System Owner for QRM Chapter within the Quality Management System.

  • Provide continued support to organizational personnel to enable sustainability of the QRM program.

Position can be based at various MSD locations in the EU.


Qualifications

Education Minimum Requirement: Bachelor’s degree in science, engineering, or related areas of study.



Required Experience and Skills: 


  • Minimum of five (5) years of relevant experience in the pharmaceutical, biopharmaceutical, medical device, or related industry.

  • Expert knowledge of cGMPs and/or Quality System regulations

  • Ability to work independently with all levels of the organization

  • Experience collaborating cross-functionally to develop and/or drive successful programs

  • Strong customer-focused mindset

  • Willing to identify and drive continuous improvements

  • Ability to handle multiple assignments

Preferred Experience and Skills:


  • Demonstrated capabilities in facilitation, preferably risk assessments using risk management tools per ICH Q9 guidelines (FMEA, PHA, Risk Rank and Filtering, etc.)

  • Experience with on the floor manufacturing processes

  • Ability to demonstrate good quality judgement in collecting and synthesizing relevant data and information and make independent and timely decisions; communicates, influences, and escalates issues and decisions as needed

  • Accountable for actions and driving results in a dynamic environment with the ability to learn from mistakes and resolve issues quickly.

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. 


 

 


Job: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Pharmaceutical, Engineer, Quality Assurance, Supply, Healthcare, Science, Engineering, Technology, Operations

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