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.
Responsible for the collation of all change control and complaint metrics for EXM DP / Devices platform. Drives continuous improvement and compliance to procedural and regulatory requirements for these systems.
Assures compliance with established policies / procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.
both domestic and foreign.
Operates in a safe and efficient manner and in compliance with our Manufacturing Division QO Safety and Health Policy.
Closely collaborates with appropriate business / operations and technical areas to achieve MSD objectives.
Collates metrics associated with change control and complaint quality systems and presents these metrics at Quality Council.
Evaluates change control and complaint trends and seeks input from External Site Quality Leads / Focus Factory
Works across the EXM DP / Device business units through change control governance to help prioritise change control approval and implementation.
Drives continuous improvement for change control in the areas of lead time, assessment and closure and works with other functions (CMC / Technical Operations) to ensure compliance to procedural and regulatory requirements.
Helps to drive standard work and templates for specific types of complaint investigations associated with devices.
BS degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent
Minimum of 3 years’ experience in pharmaceutical industry witha thorough knowledge of quality systems, regulatory requirements and GMP.
Must have knowledge of and broad experience in product Quality Assurance and Quality Control activities.
Must have strong demonstrated interpersonal, communication, negotiation, persuasion skills, must have very strong relationship building skills.
Communicates easily in English both verbally and in writing.
Must have a continuous improvement mindset.
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.