HireDiversity

Lancaster, PA, US

QUALITY RISK MANAGEMENT MANAGER, CD-6272120606

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Manager, Quality Risk Management (QRM) located in Lancaster, 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, Mylanta and ROLAIDS® antacid products, and SUDAFED® nasal decongestants.

McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us….

Creating the future of McNeil

The role of the Manager, Quality Risk Management (QRM) is to lead and direct the implementation risk management processes, procedures, training and tools at McNeil Consumer Healthcare (MCH) sites. The Manager, QRM will support the MCH sites and functions by identifying, mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that QRM is incorporated throughout the lifecycle of the products and processes.

The Manager, QRM is accountable for assisting in achieving CD work plan deliverables associated with the defined milestones at their respective site. Ensure completion of the Numbered and Lettered Steps in the Consent Decree work plan, as well as the closure of all gaps identified in the Quality System Elements (QSE) Roadmaps (derived from 483's, Quantic Baseline Inspection, deviations, Interim Controls, PVQIA, etc).

As a member of the Quality Assurance team, the incumbent will also contribute to strategic and operational tasks related to quality and compliance base business activities.

The Manager, QRM will:

Be the site's liaison between the local QRM teams/QSE's and the McNeil Home Office Group for Risk management initiatives. Lead the Quality Risk Management Process to conduct quality risk assessments for the facility, manufacturing process and products as per McNeil standards. Participate in data driven risk assessments (risk identification, analysis and evaluation), formulate strategies for risk control and ensure periodic risk review. Implement a risk assessments approach including the use of process mapping and preliminary risk assessments for determination of the Critical Quality Attributes and Critical Process Parameters. Evaluate and communicate quality/compliance risk and identify mitigating strategies. Recommend, initialize and/or sponsor corrective actions and continuous improvement. In coordination with the Site QRM Product/Process Owners and the Quality organization, work to develop and implement a sustainable framework of Quality Risk Management processes/procedures, tools, training and metrics to monitor the ongoing QRM program. Develop risk management standards and best practices documentation required to support the QRM program. Review and ensure that McNeil operating procedures and standards are developed and implemented in accordance with FDA regulations, Industry guidance's and ICH documents related to risk management. Coach, mentor and train team members through project execution. Act as change agent for team and organization relative to the new way of working. Participate in, and lead when appropriate, investigations related to department or McNeil network system non-conformances.

Qualifications


A minimum of a Bachelor's Degree in science, engineering or related discipline is required. A minimum of 5 years of Quality Assurance/Compliance experience in the pharmaceutical, biotech or medical device industry is required. Advanced degree and Six Sigma certification is highly desirable.

Experience working in an FDA regulated pharmaceutical plant environment is required. Demonstrated experience leading projects or managing functions associated with a variety of Quality Assurance activities is preferred. Thorough working knowledge and hands-on experience with ICHQ9 and the implementation of quality risk assessment and process excellence programs is preferred. Demonstrated experience leading matrix teams is required.

Extensive understanding of ICH Q9 (Quality Risk Management), Regulatory requirements and industry guidances is required as is extensive GMP, GxP experience. A thorough understanding of cGMPs for prescription or over the counter products and systems used in their deployment is required. Excellent communication skills - written and verbal are required. Proven ability to deliver on complex, cross functional projects is required. Demonstrated systems thinking, strong analytical, technical, problem solving and organizational skills are required. The ability to communicate with Subject Matter Experts (SMEs), QRM Decision Makers and other QRM Stakeholders is required. The ability to drive and conduct, if required, Risk assessments or to serve as a facilitator in the use of QRM tools is preferred. Demonstrated competence in the application of QRM principles as they relate to Quality by Design (QbD) and current Pharmaceutical Risk based process validation requirements is preferred. Experience in authoring QRM plans and Quality Risk Communication reports is preferred. Versed in basic enterprise computing platforms, architectures and technologies (SAP, MS Office) is preferred. This position will be based in Lancaster, Pa. and will require up to 20% travel.

Assignment duration of the Quality Risk Management Manager, CD to last through December 2014.

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.

Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)