Associate Director, Quality Line Oversight:
Merck

MAN004886-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: MAN004886

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 Associate Director, Quality Line Oversight, will be responsible for the management and oversight of the Quality team performing AQL checks, Line Clearance checks and other run the business or continuous improvement activities in the filling and packaging operations at the West Point site. The Associate Director will have overall responsibility for the performance and results of the Quality Assurance Shop Floor Team. Some off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Additional responsibilities include the following: 

  • Builds talent by coaching and developing the members of the Quality team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues. 
  • Develops salaried staff through coaching, assignment selection and associated training.
  • Responsible for rotating team members through shifts and assignments to IPTs to provide cross functional experience. 
  • Manages team resources and prioritizes as aligned with business needs to include run the business activities, project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. 
  • Recruit and hire team members as necessary.  
  • Responsible for scheduling team members to cover required activities. 
  • Collaborates and engages with multiple functional organizations such as Operations, Technology, and, Automation, among others, to develop and maintain processes that meet cGMP and business requirements. 
  • Participates in regulatory inspection and audit activities for the site.
  • Provides guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of documentation including investigations, protocols, qualifications, validation etc. as required. 
  • Responsible for presenting program related documents (training records, batch records, logs, etc.) to regulatory agencies during inspections.

Qualifications

Education:

  • Bachelor's Degree or higher in Business Administration, Science, Engineering or another technical field 
Required:
  • Minimum six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain 
  • Minimum two (2) concurrent years’ experience handling direct reports 
  • On the floor manufacturing shop experience
  • Demonstrated self-starter with capability to develop innovative solutions to challenges.

Preferred:
  • Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion 
  • Demonstrated experience of interacting with site, divisional or regulatory audits
  • Demonstrated ability to create an engaged workforce using Inclusion as the How 
  • Demonstrated success with Talent Management including leading and mentoring junior staff
  • Quality Systems knowledge
  • Proven ability to manage multiple projects simultaneously. MPS experience - LSS Green Belt certification or equivalent experience.
  • Compliance – Has experience and ability to achieve compliance goals, through a risk based approach has a deep understanding of GMP and EHS compliance and compliance risk in Sterile Operations. Direct Health Authority Audit experience desirable. 
  • Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm
  • Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes
  • Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. 
  • Applies knowledge of internal/external business challenges to improve products, processes or services. 
  • Solves complex problems; takes a new perspective using existing solutions. 
  • Works independently, receives minimal guidance. 

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: Manuf./Operations Generic
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Employee Status: Regular
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Company Trade Name: Merck
Basic Qualifications
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