Merck Director, Danville Site Quality Operations Head in Danville, Pennsylvania

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.

Responsible for establishing and maintaining quality policies and for discharging all quality responsibilities at an API plant in the U.S. These activities include the broadest possible involvement in every aspect of plant operations related to the quality of products produced. The incumbent is responsible for the release of all manufactured products (active ingredients, interplant intermediates, as well as materials for clinical trials produced at the plant under the direction of MRL) and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and company policies. Plays a primary role in validation activities at the plant. The incumbent acts as key regulatory compliance liaison to interface with regulatory agencies. The incumbent exercises a leadership role in maintaining the plant’s compliance with the Current Good Manufacturing Practices, Regulations (domestic and foreign) and other pertinent legal requirements. Responsible for preparation and budgetary control of a Profit Plan and capital expenditures. Directs a staff of approximately 40 people to support quality operations necessary to assure quality of goods.

Possesses unique combination of analytical/scientific skills as well as excellent managerial skills in order to effectively manage and control all activities necessary to support total Quality Operations program governing API operations. Reports to the VP Quality Operations – NACC or designate. Receives guidance on policy issues when necessary, and receives only general direction with regards to operations; discharges all responsibilities independently.

  • Directly supervises the activities of 4-8 professionals; manages the finished goods, raw materials, in-process, instrumental and Quality Assurance sections. Indirectly supervises approximately 40 individuals comprised of first line managers, professional chemists, analysts, specialists, and technicians (in some cases Union staff). Is responsible for hiring and training competent employees, administers all personnel policies and development programs. Adheres to the terms of union contracts insofar as they pertain to organized employees on the staff.

  • Is the central figure of Quality Operations at the plant site, directs the plant GMP program. Must be conversant with all regulations and compendia (domestic and foreign) governing plant’s operations. Must have sound knowledge of a wide variety of analytical, chemical, microbiological, instrumental, and automation disciplines.

  • Plans, directs, and coordinates all Quality Operations activities to assure production plans are met.

  • Assures that the Quality Operations Department operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.

  • A principal responsibility of the incumbent involves the releasing of all active ingredients or intermediate to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck and in 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 under proper conditions. This includes abnormality investigations.

  • Is ultimately responsible for the release of all purchased materials (raw materials, ingredients, packaging components, containers and closures) with assurance to plant management that all quality specifications are met. Monitors efforts to improve vendor’s quality and reliability through vendor certification programs.

  • Provides round-the-clock analytical testing support on a timely and reliable basis for product operations (in-process controls); plays an important role in establishment and review of in-process controls for all operations.

  • Operates facilities in a safe and efficient manner and in compliance with the MMD Safety and Health Policy.

  • Maintains state-of-the-art laboratory and inspection areas for finished goods testing to assure compliance to Quality Standards of purity, and stability where appropriate. Provides necessary services to assure validation of factory and other systems as required (ultra filters, computer control systems, Lab Information Systems).

  • Provides technical and scientific support, services, etc. to the plant to facilitate and validate new product introductions. Provide primary analytical role to Technical Operations in quality problem resolution and in support of new methodology and process development. Is responsible for assuring appropriate investigations have been performed to resolve abnormalities during production.

  • Maintains an excellent relationship with other plant departments as well as other Divisional/Interdivisional area heads as necessary. Is responsible for handling all FDA or other official visitors in accordance with policy, prepares written reports of such visits and responses to any findings.

  • Maintains and directs an on-going program to improve efficiency of the department through introduction of new technology (including on-line in-process controls where applicable).

  • In addition to testing and inspection performed in connections with products components and processes, service testing and inspection must be supplied for other departments in the plant and in areas of expertise for other Quality Operations Departments and for other divisions of the company.

  • The incumbent plays a key role in coordinating complaint investigations. This involves problem resolution involving product inquiries and quality complaints, and provides direction on fitness of returned goods.

Education Minimum Requirement:

  • B.S. in Chemistry or Chemical engineering (or equivalent).

Required Experience and Skills**:

  • Must have strong knowledge of GMP compliance and API operations.

  • Must have sound knowledge of analytical, organic and physical chemistry, GMP’s and Merck/Cherokee quality policies and procedures, and safety and environmental policies and procedures as they pertain to the operation of the department.

  • Must be conversant with the official compendia and methods of analysis.

  • Strong managerial skills are also essential.

Preferred Experience and 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.

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Quality Operations

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Director, Danville Site Quality Operations Head

Primary Location: NA-US-PA-Danville

Requisition ID: QUA007466