Requisition ID: QUA006099

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.

You will be responsible for implementing Quality Operations (Quality Assurance and Quality Control) policy, and discharging all QO responsibilities, supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of sterile and non-sterile pharmaceutical products in an independent manner. These activities include assuring that products are produced from approved processes, in conformance to all applicable regulatory requirements and Company policies and may include the release of all manufactured products. The successful candidate will serve as a subject matter expert for EQA and MMD in specific Quality systems, technology platforms, regulatory expectations and/or EP management and is capable of representing MSD in outside forums on their area of expertise. Thee will drive complex cross-functional initiatives to develop or optimize Quality/business processes and provide support to build effective quality systems and drive continuous improvement activities at the EP.

Activities include:

• Assures that the Quality Operations department of the EP operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
• Leads a team of 15 to 20 Quality profesionals.
• Serves as a EQA and MMD subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EP management. Utilizes this expertise to drive improved and complaint processes/systems for EQA and MMD.
• Assures the development and maintenance of a Quality Agreement with the EP’s. Provides input into the development of contractual agreements with the EP’s.
• Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
• May have the responsibility for oversight of an EP involving releasing sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologics, drug delivery devices and consumer care products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies and procedures of Merck and compliance with all governing regulations.
• Before shipment, he/she will assure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions.
• Has responsibility for Quality assurance and control functions to include direct support to EP’s, coordination and oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight. These components may include review of batch documentation and deviation investigations.
• Has responsibility for maintenance and oversight of ongoing supplier performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews.
• Reviews all audit outcomes pertaining to the EP’s and ensures appropriate and timely corrective actions are identified and implemented.
• Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums.
• Provides support to the EP’s to facilitate and validate new product introductions. Provides compliance input and support, as appropriate for implementation of analytical methodology and process development initiatives. In conjunction with other internal Merck departments, ensures that EP’s are inspection ready for all new product introductions or transfers.
• Develops presentations for Quality Council meetings. Provides oversight for presentation content and may support issuance of minutes.
• Coordinates significant investigations including Fact Findings and product recalls as needed.
• Operates in a safe and efficient manner and in compliance with the MMD Q.O. Safety and Health Policy.
• Conducts quality due diligence assessments for pre-approval considerations of new EP’s. Supports the EP in remediation of due diligence and pre-contract audit gaps. Assures the development and maintenance of a Quality Agreement with the EP. Acts as the Quality expert on Merck's behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the EP on quality related terms.
• May act as a the regulatory compliance liaison on MSD’s behalf to interface with regulatory agencies.
• Closely collaborates with appropriate business and operations areas to achieve MMD and MSD objectives.

Note: Travel should be expected up to 25% of the time.

Minimum Education Requirement:

Degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent).

Required experience/skills:

Strong knowledge of and broad experience in Quality Assurance and Quality Control activities.
Must have site leadership experience.
Working knowledge of all domestic and foreign regulations governing GMP plant operations.
Demonstrated personal networking and relationship building skills.
Strong demonstrated communication skills

Preferred experience/skills:

Experience overseeing a 3rd party manufacturing network in a global environment