MES Quality Operations Manager-9170121113
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for an MES Quality Operations Manager, located in Fort Washington, PA.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.
The MES Quality Operations Manager is responsible for ensuring that GxP site regulated Manufacturing Execution Systems (MES) & Quality Operations processes are in compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and oversight to site Quality & Operations teams for MES related projects and base business operations. They will also partner with IT to design and deploy interfaces between MES and SAP, and between MES and different Level 2 systems, and must understand what each one of these components provides.
Primary responsibilities of the Quality Operations Manager include but are not limited to: Providing Quality oversight for the design and deployment of MES systems to replace paper based or manual systems including batch records, weigh & dispense, warehouse management and material tracking in a pharmaceutical like environment; Lead compliance review meetings; Create, modify, review , and approve SOPs , test scripts, end user training materials, design and validation documents; Partner with IT to gather user requirements in relation to controlling and recording manufacturing activities; Lead and execute project s to harmonize Quality MES processes across McNeil facilities, the Consumer Sector sites and other J&J organizations; Create, modify, review, and approve other compliance-related documents (e.g. Change controls, Assessment plans, Risk assessments, Non-conformance reports, Corrective and preventative actions, Audits reports, Position papers on QA topics. This individual is also responsible for conducting training, participate in regulatory inspections and drive corrective actions.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
A minimum of a Bachelors degree is required. A focused degree in chemistry, microbiology, engineering or a science related field is preferred. A minimum of 5 years of QA Operations functional experience within the Pharmaceutical, Medical Device & Diagnostic and / or OTC Drug industry is required. It is required to have a deep understanding of Drug cGMP's and the systems used to deploy them. Experience with Non-Conformance and CAPA systems is required. Demonstrated documentation and technical writing skills, in a regulated compliance environment, is required. QA Management experience is preferred. IT and systems knowledge is highly desirable. Experience with Six Sigma Process Excellence tools, training and / or certification is preferred.
Strong validation (Process, Computer Systems, Cleaning) experience is preferred. Previous experience deploying or supporting an Electronic Batch Record (EBR) or MES solution such as ProPack, Werum Pas-X, Camstar or Elan is essential. Experience with Werum Pas-X preferred. It is required to have experience with the following job-specific areas of SAP: MM, WM,IM, PM, QM and BW. Knowledge of shop floor control software is preferred. This individual must be able to work and make decisions independently and have the flexibility to adapt to changing priorities. It is required to have strong leadership skills and the ability to work in cross-functional team environments. Strong written and verbal communication skills are essential.
This position is located in Fort Washington, PA and may require up to 20% travel.
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Primary Location: North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Johnson & Johnson Family of Companies
- 2 years ago - save job
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