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Quality

Senior Manager, Product Quality Management (PQM)-Excellence Lead

  • Titre Senior Manager, Product Quality Management (PQM)-Excellence Lead
  • Fonction Quality
  • Sous-fonction Business Process Quality
  • Catégorie Senior Manager, Business Process Quality (P8)
  • Lieu Titusville, New Jersey, United States; United States
  • Date de mise en ligne
  • Référence 2406187175W
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Description

Johnson & Johnson is currently recruiting for a Senior Manager, Product Quality Management (PQM)-Excellence Lead! This position can be performed remotely in the North America or EMEA regions. Remote work may be considered on a case-by-case basis and if approved by the business.

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.

Key Responsibilities:

·       Have accountability for developing and executing Product Quality Management (PQM) Technology roadmap to support operational agility and efficiency.

o   Develop, Manage, and communicate the PQM Technology Roadmap.  Part of the communication will be internal to PQM, and part will be to Innovative Medicine Quality Digital, Data and Analytics (DD&A) group.

o   Establish/update/manage LRFP and yearly PQM budget, capital funding (aCAR) development, and business case development related to roadmap execution. 

o   Be the project manager for PQM technology roadmap projects and many aCAR processes.

o   Translate PQM application needs to user stories and user requirements for implementation by J&J Technology Business Analyst.  Maintain a cadence of obtain requirements from functional areas within PQM.

o   Lead deployment/change management within PQM for deployment of new application or updates to existing applications.

·       Be direct responsible Quality partner to Therapeutics Development & Supply (TDS) organization for electronic Reporting related activities.

o   Collaborate with R&D on unified data model to allow for improved and streamlined dossier authoring, including automation of technical reports such as specification, criticality analysis, stability reports, etc.

o   Critical participant in the technical translation of business to system requirements and understanding of the unified data model connecting data fields across the different electronic Reporting modules with specific focus on quality topics.

o   Post implementation develop user stories to resolve technical issues.

o   Support onboarding of users into digital applications.

o   Work with R&D and application vendor to determine user stories that improve automation for PQM specific interests within.

·       Establish/adapt quality system/process/procedures to enable implementation of advanced analytics applications in product development/commercial manufacturing such as PAT, continuous manufacturing, real time release. 

Qualifications

Education:

A Minimum of a Bachelor's or equivalent University degree is required with a focus in Pharmaceuticals, Chemistry, Engineering, Statistics, Sciences preferred. Advanced degree and/or Business (MBA, MS or PhD) is preferred.

Experience and Skills:

·       At least 7 years of related experience in Medical Device/Biotech/Pharmaceutical Industry.  Preferred experiences in roles related to pharmaceutical product development or testing.

·       IT related expertise

o   Implementation experience in one or more of the following disciplines: large scale data integration across platforms, application development, application programming interfaces (APIs) or database management

o   Familiarity with data warehouse, data lake, and enterprise big data platforms

o   Knowledge or experience with programming languages such as R or Python (strongly preferred)

o   Demonstrated experience in business integration solutions with different interface types: batch interfaces, near real time interfaces, and real time interfaces.

o   Strong understanding of software development lifecycles, including release and validation management

o   Experience in delivering validated software in a regulated industry.

o   Experience working with AI/ML-powered technologies.

·       Experience working in an Agile environment.

·       Ability to translate business needs into technology requirements and solutions.

·       Experience in developing business case and budget planning

·       Excellent written and verbal communication and social skills, and a consistent track record to build and maintain relationships with internal and external partners.

·       Strong project management skills, with experience leading cross-functional teams and ability to manage multiple projects/ teams simultaneously

·       Ability to work with multi-functional and business partners globally.

Other:

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

·       This position has an estimated annual salary of 118,000- 236,000 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.]

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