Associate Director, Supplier Quality Assurance Job

Employer
Merck
Location
Madison, NJ, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006246

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 primary purpose of the position is to help ensure that all products or materials supplied to Merck Animal Health from a set of key suppliers are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands.



The incumbent is responsible for supporting total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager or Director. The incumbent exercises a coaching role in guiding the Third Party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements.

Responsibilities:



  • Reports to the Director, Supplier Quality Assurance for External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Director informed on the status of operations and when challenges, opportunities and/or issues arise.

  • Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement; ensures the Quality Agreements are kept up to date and ensures review of the Quality elements in the Commercial Agreement

  • Acts as Merck-AH Quality Operations point of contact to defined key suppliers and as the Quality liaison between the external partner and the internal company personnel. 

  • Supports Merck Animal Health audit plans and effective execution of subsequent remediation by the partner; may also perform separate audits 

  • Conducts regular site visits to support training and coaching to initiate quality improvements within the partners’ Operations where necessary.

  • Assures Quality requirements on Change Proposals submitted by the partners conform to all requirements. 

  • Reviews all Deviation investigations submitted by the partners and supports further investigation where necessary.

  • Support Product Quality Complaint (PQC) investigations with the relevant suppliers 

  • Support Technology Transfer projects for the relevant suppliers 

  • Assures guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable

  • Support effective preparations at the third party for regulatory inspections (where required). 

  • Effectively contributes to cross-functional investigations and project teams.

  • Completes additional Quality related activities as required to fulfil the role.

Qualifications

Education:




  • Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)

Required Experience:


  • Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP 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 manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.

  • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues 

Preferred:





  • Preferably to have Auditor training (example ISO 9001)

  • Useful to have second language skills


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 an accommodation for the application process please email us at 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: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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