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J&J Family of Companies Manager, Innovative Medicine Quality Systems Management in Malvern, Pennsylvania

Manager, Innovative Medicine Quality Systems Management - 2406194621W

Description

Johnson & Johnson is currently recruiting a Manager, Innovative Medicine Quality Systems (IMQS) Management ! This position can be located in Titusville, New Brunswick or Raritan, NJ, Horsham or Malvern, PA.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary

The Manager, Innovative Medicine Quality Systems (IMQS) Management is responsible for the overall ownership of the IMQS end to end Quality System Management Review (QSMR), Intercompany Quality Agreements (ICQA) and Quality Management Maturity processes. Interfaces with partner functions to standardize, harmonize, monitor, and improve the overall Quality System processes. This role will have key collaborations with Digital, Data & Analytics, Risk Management, Quality Process Owners and functional area leaders E2E. Supports Quality Management Maturity initiative.

Key Job Duties and Responsibilities:

  • Perform related duties as assigned by supervisor and participate in assigned special projects

  • Maintain compliance with all company policies and procedures

  • Support and monitor the implementation of the Enterprise and IM Quality System Strategy to ensure alignment to standardize processes

  • Partner with Digital, Data & Analytics in the execution of the IM D&A Strategy

  • Create, implement, and maintain procedures, reports, training materials, and tools for standard processes including delivery of training and information sessions

  • Provide input to design of dashboards and scorecards that will allow for the visualization of key performance indicators in line with the IMQS vision, strategies, goals, and objectives

  • Represent IMQS to Enterprise quality organization to provide IM inputs for Enterprise Quality Reviews (EQR) and quality leadership monthly metric reports

  • Coordinate semi-annual IM Group Operating Committee (GOC) Quality Reviews and GOC Risk Reviews

  • Responsible for overall IM QSMR process and ensures sector alignment to Enterprise Standard and SOP requirements

  • Lead IM Metric Council to drive alignment for QSMR and metrics collection, address issues, problem solve, knowledge share, create tools and identify best practices across the segment

  • Coordinate and lead monthly IM Quality System department metric reviews and periodic quality updates

  • Serve as subject matter authority point of contact to IM Quality Functional Leads for metric collection and analysis

  • Work with quality system process owners and users to trend and analyze applicable data and identify improvements through user feedback, data analysis, and connecting processes end to end

  • Enter manual metric data for IM in designated electronic system (e,g.: Voyager Metric Portal)

  • Oversight of Intercompany Quality Agreements (ICQA) procedures and processes

  • Provide Quality System support for processes including but not limited to Quality Management Maturity and Risk Management

  • Maintain and update IMQS Risk Register and collaborate with Enterprise and IM Risk Management Teams

  • Stay ahead of external trends and best practices regarding metrics, data and analytics, QSMR, ICQA, Quality Management Maturity, and Risk Management. When applicable participate in external benchmarking groups and requests.

Qualifications

Education:

A minimum of Bachelor's or equivalent University degree is required with a focus in a technical field such as Science, Engineering, or a related subject area preferred.

Required:

  • 6-8 years experience in a pharmaceutical or similarly regulated GXP industry including experience in Quality Systems, Metrics & Analytics or a related field

  • Previous experience at manager level with demonstrated track record of successful results

  • Excellent verbal and written communication skills, including ability to effectively connect with internal and external customers

  • Computer proficiency in Word, PowerPoint, Excel

  • Experience with data analytics/visualization software (e.g. TABLEAU, SPOTFIRE, Power Bi, etc.)

  • Analytical skill to identify gaps and root causes of issues and think out of the box to develop solutions

  • Able to work independently with minimum supervision to meet timelines while maintaining a positive demeanor

Other Key Skills:

  • Ability to lead in the context of Our Credo

  • Flexibility to work in a global environment

  • Experience with Executive level interactions and presentations

  • Lean certification or Green Belt or higher preferred

  • Ability to build interdependent partnerships, acting as the mediator between organizations while optimizing the value proposition

  • Ability to influence partners at different levels in the organization

  • Analytical skills and experience leading risk-based oversight programs

  • Statistical knowledge

  • Collaborative approach and ability to connect with colleagues

  • Ability to lead during complexity and ambiguity

  • Problem solving skills

  • Prioritization skills

  • Project management skills

Other:

  • This position may require up to 10% domestic & international travel.

  • This position has an estimated annual salary of 99,000- 197,000 USD$

    • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

  • This position is eligible to participate in the Company’s long-term incentive program.

  • Employees are eligible for the following time off benefits:

  • Vacation – up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year

  • Work, Personal and Family Time - up to 40 hours per calendar year

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Primary Location NA-US-Pennsylvania-Horsham

Other Locations NA-US-New Jersey-Bridgewater, NA-US-New Jersey-New Brunswick, NA-US-New Jersey-Raritan, NA-US-New Jersey-Titusville, NA-US-Pennsylvania-Malvern

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Travel Yes, 10 % of the Time

Job Function Quality Systems

Req ID: 2406194621W

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