Job Detail

Associate Director, External Manufacturing Quality (Sterile Drug Products)-QUA008101 

Description

 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.  Our Manufacturing Division 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.  The Associate Director, External Manufacturing Quality (Sterile Drug Products), will be responsible for leading a Quality team for the qualification/startup for a facility that will manufacture sterile products at external Contract Manufacturing Organizations located in Europe.    Primary responsibilities will include but are not limited to: 

• Oversight of Contract Manufacturing during qualification and startup activities by providing technical project management leadership and Quality oversight for manufacture and  testing  of sterile products.


• Inspection readiness activities for global markets.


• Author, review and/or approve technical documents including deviations, CAPAs and Change Controls. 


• Provide on-site support for pre-licensure audits


• Contribute to the creation of regulatory filings and Agency notifications.

 This position will report into Jennifer Ryan (Director, External Quality Assurance) and the location for the position will be either MSD Lucerne office or surrounding areas.

Qualifications

 
Education Minimum Requirement:   

• Bachelor's degree in engineering, science, or related areas of study.

 
Required Experience and Skills:   

• At least 10 years pharmaceutical manufacturing experience (GMP).


• Previous experience in sterile pharmaceutical, vaccine or biologic drug product manufacturing/support is required.


• Aseptic manufacturing experience, experience with EMA and FDA (CBER or CDER) inspections and knowledge of multi-national regulatory agency cGMP expectations required.   


• Communicates easily in English both verbally and in writing.
  

Preferred Experience and Skills :

 

• Previous experience as a people manager (via direct reports or matrix organization). 


• Previous experience with regulatory communications such as Biologics License Applications (BLAs), New Drug Applications (NDAs).


• Direct experience with managing external partners strongly preferred. 


• Knowledge of GMP requirements for Device/Combination Products.


• Familiarity with analytical assays for sterile vaccine/biologic drug product


• Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ) 

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

Primary Location

: EMEA-Switzerland-LU-Luzern

Other Locations

: EMEA-Italy

Employee Status

: Regular 

Number of Openings

: 1Company Trade Name:MSD