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.
Individual contributor responsible for ensuring that all MSD products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with MSD expectations and all applicable regulatory requirements.
The ESQL serves a leadership role in the management and oversight of External Partner / External Party (EP / ExP) operations related to the quality of products produced, and will manage or provide guidance to EQA Product Quality Managers (PQM) who have primary responsibility for batch release and other day-
to-day activities at the EP / ExP (i.e. deviations, change control, SAP transactions, etc.). Additionally, the ESQL drives complex cross-
functional initiatives to develop or optimize Quality / business processes at the EP / ExP.
ESQL will manage partner relationships of increasing complexity, as defined by one or more of the following : number of products manufactured, number of partners managed, production volumes, impact of products to MSD's revenue, number and complexity of in-
markets, regulatory history, historical performance (production and compliance), new product or market launches, historical relationship between MSD and the partner, manufacturing process complexity.
The incumbent ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP / ExP’s manufacture of materials for MSD (e.
g. API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals, drug delivery systems, Medical Devices) through direct oversight, support and technical advice, counselling to site leadership, and on-
site supervision. The ESQL is also responsible for all aspects of end to end EP / ExP performance, and serves as the primary contact for the relationship, applying risk-
based approaches and driving continuous improvement activities at the EP, where needed. The ESQL may serve as a subject matter expert for EQA and Manufacturing Division in specific Quality systems, technology platforms, regulatory expectations and / or EP management, and is capable of representing MSD in forums on their area of expertise (both internal & external).
Primary Activities include, but are not limited to the following :
both domestic and foreign
review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted)
e. stock out situation) of the market
Required Skills :
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.
Search Firm Representatives Please Read Carefully :
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.
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No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.