Director External Quality Assurance Distribution & Logistics Job – Merck / MSD – West Point, PA, USA
This position ensures that all Merck/MSD products are stored and distributed in accordance with all applicable Merck and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations. The incumbent leads the Center of Excellence for Logistics and Cold-Chain Quality, with responsibility for establishing and leading MMD strategic initiatives to ensure MMD/MSD compliance with Good Distribution Practices.
– The position ensures the quality performance of the Supply Chain Management-Logistics network and the associated External Partners (Distribution/Transportation) through direct oversight, support and technical advice, counseling to the partners’ site leadership and providing on-site supervision as appropriate.
– This includes overseeing activities such as Partner Selection, GDP Due Diligence evaluations, establishing Quality Agreements; Quality Assurance including permanent audit readiness, tracking partner Quality metrics, providing coaching and training; Quality Control such as importation testing, atypical investigations and change control requests.
– This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities at partner sites.
– Directs a multi-layered global COE of 14-20 people and advises regional and divisional management on external quality issues related to distribution, logistics, and cold-chain activities.
– Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent).
– Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.
– Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent).
– Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP, GDP and regulatory requirements.
– Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
– Must have the ability to influence management of complex distribution operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
– Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity
– Must have exemplary people/team leadership experience, including leading and motivating teams. Experienced in establishing performance metrics and holding people accountable for results.
– Integrate: Ethics & Integrity.
– Integrate: Courage.
– Impact: Deliver Customer Value.
– Impact:: Make Sound Business Decisions.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Job: Qual Assurce – 3rd Party Manuf
Job Title: Dir, External Quality
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NC-Wilson, NA-US-NJ-Whitehouse Station West
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck