MSD Assoc Dir External Quality 

Switzerland, Lucerne 

439364117

Job Description

We are currently seeking an Associate Director External Quality who is accountable for activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.

The incumbent is also a subject matter expert for both EQA and manufacturing division in specific Quality Systems, technology platforms, regulatory expectations and/or external entity management. The incumbent may also serve as the representative of our company in outside forums on their area of expertise, driving complex cross-functional initiatives to develop/optimize Quality/business processes applying risk-based approaches and driving continuous improvement activities at the external entity.

• Accountable for all aspects of end-to-end External Entity performance, and serve as the primary contact for the relationship, apply risk-based approaches and drive continuous improvementactivities
• Provide leadership and direction to help execute a risk-based system for calibrated quality oversight based on the product type as well as the capabilities and quality performance of an external manufacturer.
• Establishes clear expectations, measures and periodic monitoring of operational and quality performance associated with External Manufacturing. Provides leadership for oversight of quality due to diligence assessments for pre-approval considerations of new external providers.
• Provides leadership and strategy to ensure the establishment and maintenance of QualityAgreements.
• Direct and manage major External Manufacturing Quality investigations, ensure that Significant Investigations and Fact Findings are organized appropriately and co-ordinate any recalls as appropriate.
• Participate as a member of an EQA Platform / Regional Leadership Team and other committees asappropriate.
• Exhibits our company Leadership Behaviors and provides a leadership example for theteam.
• Works strategically and in collaboration with other functions to continuously improve our company's effectiveness and efficiency in quality management and quality systems supporting the external network.
• Moderate level of contractual and financialawareness.
• Prior people management experiencepreferred.
• Ability to travel 25%, occasionally on short

REQUIRED: Education and Experience:

• Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
• Minimum of 12 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Experience in Sterile Manufacturing/ PSIM required
• Strong experience required in Deviation Management, Change Control and support of filings
• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadershipskills.
• Communicates in English, both verbally and inwriting.

Current Contingent Workers apply

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