Associate Director, Domestic and International Release Lead:
Merck

QUA006798-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: QUA006798

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 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. 


The Domestic and International Release Lead reports to the Director, West Point Quality Operations and is responsible for implementing Divisional, Company and Site policy, procedures and guidelines for domestic and international release activities for West Point Quality Operations.
The Domestic and International Release Lead requires strong quality/analytical/scientific skills as well as excellent leadership abilities in order to effectively support West Point Quality Operations. Strong collaboration, communication, and decision making are key attributes for this role. The Domestic and International Lead consults and receives guidance from the Director, West Point Quality Operation when necessary.

  • Act as the primary quality contact for West Point for batch release question/concerns from worldwide batch release and regulatory agencies and Merck vaccine release sites. Must be familiar with all regulations and compendia (domestic and foreign) governing site operations. 
  • Provide support and guidance to West Point Quality Operations in the development and improvement of quality processes and resolution of domestic and international batch release issues. 
  • Maintains quality release systems and drives compliance within West Point Quality operations. 
  • Maintain batch disposition subsystem owner role and perform responsibilities as required per QMS and site procedures. 
  • Lead Domestic and International Release Community of Practice committees to discuss batch release issues and ensure alignment within West Point Operations and Durham quality, identify and implement improvements, and share best practices.
  • Author, review, and/or approve Agency Communications for batch release including discussion of lot specific investigations, potential GMP discrepancies, and interpretation of Regulatory Filings as they impact lot release.
  • Responsible for coaching and teaching WP Quality release personnel on batch release related activities and policies. 
  • Operates in a safe and efficient manner and in compliance with the MMD QO Safety and Health Policy. 
  • Support Site Quality Leadership in the development, implementation, and review of strategic quality initiatives.

Qualifications

Education: 

  • BS in Science or Engineering. Advanced degree preferred.
Required:
  • 5 years experience in the Pharmaceutical industry.
  • 5 Years experience in Quality Product Release, with a minimum of 3 years in International Product Release 
Preferred:
  • Strong understanding of cGMPs and worldwide regulatory standards 
  • Demonstrated leadership and management experience working with cross-functional teams on complex projects
  • Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting

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.

 

Visa sponsorship is not available for this position.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement