Associate Director, Quality Assurance, Integrated Development and Supply Teams Quality Lead

Employer
Merck
Location
West Point, PA, US
Posted
April 10 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: CLI007172

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


Under the direction of the Integrated Development and Supply Teams (IDST) CoE Quality Leader, the full-time Quality Lead will represent the Quality organization and be responsible for the quality issues in support of the Integrated Development and Supply Teams (IDSTs). The incumbent will participate in the IDST core teams, and ensure compliance with all regulations to support commercialization of products from late phase development through launch. 
The candidate will be responsible for engaging and participating in activities and ensuring connectivity to the Quality systems. The candidate will develop strategic direction by providing teams with the understanding of quality guidances, preparing and reviewing team plans and assisting in executing the plans to achieve aggressive timelines. In addition, the incumbent is responsible for establishing and promoting a strong inclusive culture through participation on the IDSTs and leading the Quality Working Group teams.

Qualifications

Education: 
    BS degree required, with concentrations in Science or Engineering (chemical or mechanical engineering, pharmacy/pharmaceutics, chemistry, biology).

Required: 
    Minimum 10 years applied professional work experience working within a manufacturing operations, quality organization, supply chain, technical operations, process research, and/or development environment. Prior experience in a Quality organization is required.Prior experience leading cross-functional teams is required. Comprehensive understanding and working knowledge of Quality systems and processes. Strong collaborative and communication skills, including ability to communicate effectively in multiple directions. Strong organizational skills and demonstrated ability to independently manage multiple priorities, ensuring timely completion. Demonstrated, strong leadership ability, including the ability to drive teamwork and employee engagement. Strong team facilitation, team organization, conflict resolution, and listening skills.

Preferred: 
    Working knowledge of the product commercialization process and the understanding of the roles and responsibility of related functional organizations within MMD and MRL. Strong ability to provide clear expectations and priorities for teams. Strong ability to manage through uncertain situations, to make decisions and to develop strategic plans for managing risk. Strong ability to resolve conflicts among people and organizations. Ability to encourage speaking up and provide diversity of thought.Solid understanding of Quality and Health Authority regulatory and compliance requirements.


Your role at Merck 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 Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Clinical, Non Clinical Quality Assurance
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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