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Quality

Manager, Business Process Quality

  • Titel Manager, Business Process Quality
  • Funktion Quality
  • Unterfunktion Business Process Quality
  • Kategorie Manager, Business Process Quality (P7)
  • Standort Horsham, Pennsylvania, United States
  • Gepostet
  • Stellenangebotsnummer 2406198539W
Bewerben
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Beschreibung

Johnson & Johnson Innovative Medicine is currently recruiting for a  Manager, Business Process Quality in Horsham, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at  www.janssen.com  and follow us @JanssenGlobal.  Janssen Global Services, LLC is part of the Janssen Pharmaceutical Companies. 

The Manager, Business Process Quality, supports all aspects of the development and maintenance of standardized processes within US Medical and Scientific Affairs (MA/SA) to enable the organization to work more efficiently and in compliance with policies and regulations.  This role serves as the project management lead for continuous improvement initiatives related to priority quality-based MA/SA processes.

The Manager, Business Process Quality, manages procedural document development, implementation, training, periodic reviews, revision and obsolescence of documents, impact assessments, process management, and contribution to associated training content to ensure consistency with the procedural documents.

In addition, this role ensures quality and compliance to processes, including identification, and resolution of compliance issues, vigilance for self-identified process improvement opportunities, and providing communications / awareness of company and compliance guidelines. This role also provides strategic insights for process-related technology enhancements and other new solutions to improve overall efficiency.

Responsibilities:

·       Manages and contributes to projects, programs, or processes to document the current state processes, identifies improvement opportunities and other workflow impediments, and innovates a future state process which fulfills the success metrics.

·       Manages projects to achieve major Business Process Quality initiatives and objectives to optimize organizational efficiencies and quality.

·       Executes process improvement opportunities aligned to business process quality objectives leading to innovative future state processes.

·       Executes roadmaps of process improvement opportunities across functional areas and in alignment with strategic business objectives.

·       Executes and contributes to quality and simplification by eliminating rework loops, reducing and automating manual work, identifying and implementing best practices, and minimizing process variability through standardization and automation.

·       Applies processes and tools to collect and measure data, identify key performance indicators (KPI), and produce a data-driven analysis of functions.

·       Works to gain commitment from stakeholders and team members.

·       Provides coaching and guidance to others ensuring appropriate use of the continuous improvement methodology, process discipline, and fact-based decisions in problem solving and decision making.

  • Monitors and ensures appropriate use of policies, processes and procedures including development / implementation of corrective action and resolution of problematic issues.  Thereafter, provides general framework on how to avoid similar situations in the future.
  • Serves as a corrective action / preventative action (CAPA) champion, including the creation / management of quality records, oversight and / or responsibility for timely closure / documentation of Quality Event Management records
  • In partnership with Learning Center of Excellence, ensure that all training materials under development follow and align to departmental SOPs; including documentation of curriculum content, work instructions, training, and notices.

·       Lead and conduct training sessions for end users including crafting training resources including curriculum development to capitalize on differentiated user experience and learning needs to ensure all partners remain current with process, including system knowledge and capabilities.

·       Assist with the creation and dissemination of VOC surveys; identification of insights, trends, and training needs to implement appropriate action.

Document, Quality Management & Quality Assurance (50% of role)

  • Audit lead for internal / external audit to develop, handle, maintain, and monitor all Controlled Documents (e.g., SOP, WI, Job Aid) including action plans for resolution of identified issues and avoiding and/or mitigating future quality issues.
  • Assist with periodic monitoring of materials approved via the MedRC process; perform monitoring assessments and proactively work with Associate Director to respond to and / or mitigate any nonconformance issues (actual or potential).
  • Actively participate in system and process validation and testing for all configuration additions or changes.
  • CAPA champion lead in achieving quality assurance results.

Training and Organizational Change Support (50% of role)

In collaboration with other relevant functional stakeholders, assist with:

·       Development, improvement, implementation, and tracking of organizational change projects in alignment with standard operating procedures, policies, goals, and objectives.

·       Demonstrate and understand the appropriate learning tools and constructs through a variety of mediums (hands-on, live, WebEx, etc.).

·       Identify, build, and distribute various communications such as system improvements, functionality changes, process updates / advancements, standard methodologies, and training resources.

·       Identify / implement training resources and communications for end user accessibility and traceability including ensuring the appropriateness of training content and resources to align with changes to SOPs, policies, and other related Work Instructions.

Befähigungen

  • Bachelor’s degree is required; advanced degree or certificate is highly desirable.
  • 3-5 years’ of relevant experience within Pharmaceutical Industry is required
  • Experience in areas of quality assurance, healthcare compliance, writing and interpreting SOPs is preferred.
  • Strong project management skills, including the management of multiple concurrent project plans,  is required.
  • Ability to collaborate and work in a matrixed organization supporting multiple stakeholders is required
  • Excellent verbal, written and presentation skills with ability to write communications for a variety of audiences is required.
  • An ability to build and maintain strong partnerships with all levels across the organization, as well as to interact effectively with senior management.
  • Understanding of regulatory and health care compliance guidelines is required.
  • Cross functional team experience is highly desired.
  • Organizational and time management skills.
  • Strong computer skills a must (i.e., Excel, Access, Word, Power Point).
  • Must be team player, customer focused, goal driven and a problem solver.
  • Exceptional communication skills, both verbal and written and confidence in presenting to broad audiences.
  • Analytical mind-set to interpret data and experiences to offer solution-based strategies.
  • Able to work well in a fast-paced environment.
  • Appropriately influence without formal authority
  • Must be detail oriented.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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