Associate Director, Quality System Standards Management Job in Fort Washington, Pennsylvania Us
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for an Associate Director, Quality System Standards Management 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, PediaCare upper respiratory medicines for infants and children, ROLAIDS antacid products, and SUDAFED nasal decongestants.
The Associate Director, Quality System Standards Management provides governance, oversight, and stewardship of the collection of Quality Standards which define the compliance requirements for McNeil's entire Quality System. This role ensures that an effective, efficient, and sustainable process exists to govern and document all quality processes at McNeil in a manner which ensures their integrity, consistency, compliance, and business value for McNeil. The position oversees document control processes, including establishment of a system-wide document library and stewardship of all multi-site standard operating procedures. The position also oversees a team of network process owners who define, develop, and implement harmonized, risk-managed quality processes in the areas of Document Control, Validation, Facilities, Equipment, Utilities, Quality Assurance, Laboratory Operations, Stability, Product Development, Materials and Components, Warehousing, Manufacturing Operations, External Manufacturing, Management Controls. The position ensures appropriate metrics are defined and measured to enable monitoring. The individual in this role performs surveillance of emerging industry trends and regulations in order to ensure continuous improvement of the McNeil quality system as defined within the Quality Standards.
The Associate Director, Quality System Standards Management, will manage processes to meet all applicable regulatory requirements at the McNeil Plants. This individual will ensure harmonized and efficient processes to assure long-term sustainability of McNeil's Quality Systems; ensure processes remain current with US and global regulatory requirements; establish and train on applicable processes and procedures; monitor compliance and effectiveness through trending, analysis, metrics, and reporting to senior management; monitor Key Performance Indicators and identify opportunities for continuous improvement; manage and oversee processes for system-wide collection and reporting of metrics that demonstrate the acceptable functioning of the quality system, and illuminating areas for improvement.
The Associate Director, Quality System Standards Management will lead a staff of professionals that serve as process owners in process definition, implementation, training, oversight of system maintenance, monitoring of Key Performance Indicators, and continuous improvement. The incumbent will demonstrate leadership and integrity while working directly with and/or influencing McNeil operating entities to ensure that the quality system is robustly implemented and operational across the organization. The incumbent will manage and provide leadership and organizational capability development, and ensure succession planning and performance standards remain at an optimal level to maintain compliance. This individual will analyze and present quality and compliance issues to senior and executive management. The Associate Director, QSSM will interact with Directors, Vice Presidents and General Managers of McNeil plant sites in all areas. This individual will manage QA personnel, organize and prioritize group tasks, perform training, and manage performance.
The Associate Director, Quality System Standards Management will actively develop and manage relationships with process users, business owners, Johnson Johnson affiliates, and external organizations to ensure harmonized and consistent Quality processes. This individual will provide guidance and direction regarding execution of Quality processes; establish external relationships in order to interpret and influence emerging trends in regulations and requirements on a global basis; ensure audit and inspection readiness of McNeil processes and documentation relative to the compliance framework for the systems managed. This individual will interact with regulatory authorities during inspections; interact with industry panels, other Johnson Johnson operating companies, and Johnson Johnson global councils to interpret and influence emerging quality processes trends.
All McNeil employees are required to cultivate an environment of quality and compliance in their actions. This includes attending all required training, adhering to the processes and 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 and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelor's Degree in science, engineering or related discipline is required with a minimum of 10 years of work experience in a pharmaceutical quality or compliance setting. Advanced degree in regulatory compliance is highly desirable.
This position requires demonstrated knowledge and expertise in quality processes and regulatory requirements. It requires experience working in a pharmaceutical plant environment; managing a quality or compliance function; working in an FDA regulated environment; leading matrix teams and managing direct reports. The ability to evaluate quality processes and recommend improvements to meet regulatory requirements is required. Project management and process excellence expertise in order to manage complex projects, determine and assign resources and individual tasks is also necessary. The selected candidate must be able to develop quality assurance processes and metrics. Knowledge of Six Sigma Process Excellence tools is required. Applicable certification is a plus. A Six Sigma Black Belt is desirable. A Certified Quality Engineer or related certification is desirable.
Experience building and managing processes involving quality system governance is highly preferred. Experience managing document control processes is preferred. Experience building system-wide metrics collection and reporting processes is also preferred.
The ability to write clear, concise technical documents is necessary. Excellent written and oral communication and interpersonal relationship skills are required. The ability to influence, negotiate and lead without direct line authority experience is required. The ability to manage complexity, manage priorities effectively, and manage a diverse team is essential.
This position is located in Fort Washington, PA and may require up to 20% travel.
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