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Director Quality System Integration Management - 2406192499W

Description

Johnson & Johnson is currently recruiting for a Director Quality System Integration 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 Director Quality Systems Integration Management role is responsible for effective deployment of the Quality Systems Strategy (Next Gen Quality System) in alignment with the IMQCLT strategy and provides portfolio process management to deliver elements as defined in the Quality Systems framework for Innovative Medicine. This role will have key collaborations with Data & Analytics, Risk Management, Quality Process Owners and functional leaders, ensure Systems Strategy and its associated deployment across the product lifecycle E2E.

Strategy: The incumbent will be responsible to work with IMQLT and other Partners to establish a comprehensive strategy and operational plan to deploy a ‘fit for future’ quality system and framework. The incumbent will define strategic vision and roadmap, ensure funding support through Long Range Financial and Business Planning and lead execution of the strategy. Ensure and Acquisition or Divestiture is coordinated appropriately within the Quality Systems Strategy.

Roadmap: The position holder will be direct responsible person to identify a roadmap to deliver on the strategy and will deploy innovative practices and tools that help the organization to successfully transform their quality operations and simplify processes and drive efficiencies for the business. The incumbent will work across all Functions in Innovative Medicine, and partner with leadership to ensure global processes are coordinated within the Quality Management System and Framework.

Key Job Duties and Responsibilities:

• Responsible for deployment of the Next Generation quality system and path toward a ‘fit-for-future’ Quality Management System for Innovative Medicine.

• Ownership and leadership of the Innovative Medicine Quality System Strategy and provide oversight of the portfolio process to deliver: an efficient and effective quality management system that aligns with the IMQCLT strategy, serve as the overall program lead for the Next Generation Quality System program, leads periodic assessment and review to ensure the strategy is aligned with the vison and mission of Innovative Medicine Quality.

• Builds supporting infrastructure (Governance, Networks, Communities, …) across Innovative Medicine with the aim to build a dynamic and effective team and program support.

• Define, maintain, and sustain the Innovative Medicine Quality Systems Strategy in alignment with business,

• Key Business Process Owner – Quality, on key programs with functional processes (partners)

• Apply sophisticated knowledge and experience to address complex issues; manage program costs, budget and resources and develop new principles/concepts.

• Establish and maintain long range financial plan, business plan and portfolio to support Quality Systems priorities and aligned with IMQLT strategy.

• Engage partners to provide input into the strategy. Ensures annual Strategic and Business Planning aligns with priorities defined within the strategy.

• Participate as Quality Systems lead on Quality team for key acquisitions and divestitures.

• As this organization continues to develop in the future, they will build a strong team, indirect and direct. Define and build metrics and to continuously monitor and analyze processes, costs, identify risks and area of opportunity based on quality indicators and communicate according to leadership.

• 80% Own and Lead Innovative Medicine Next Generation Quality Management Systems strategy, framework, deployment, execution, and organizational support. Responsible to represent quality on other key programs defined by IMQLT/partners

• 15% Quality Systems long range financial plan, business plan and portfolio management to support Quality Systems priorities

• 5% Collaborate and support acquisition and divestitures from Quality Systems perspective

Additional Duties/Sphere of authority

Execute responsibilities as Strategic Program lead for Next Generation Quality Systems:

• Ensure deployment of an effective implementation of Quality System processes to align with the Quality System strategy,

• Lead people, budget, and timelines to meet established goals,

• Maintain documentation related to GxP activities and status in accordance with Johnson & Johnson Quality Standards and local regulatory requirements,

• Review and report on performance and status to appropriate level of management, within Innovative Medicine and partners,

• Raise quality, regulatory compliance, and process issues as appropriate,

Serve as key contributor for the Janssen Quality Systems steering committee, ensuring distribution of key information to a network of Leaders across Innovative Medicine:

• Co-Leads facilitation of the Janssen Quality Systems Steering Committee

• Participates in periodic assessment and review to ensure the strategy is aligned with the Vision and Mission of Innovative Medicine Quality

• Helps to develop the preparation for Janssen Quality Systems Steering Committee Meetings.

• Supports all aspects of governance of committee (ie: content of speakers, meeting agendas, meeting facilitation, preparation of minutes and tracking of action items).

• Stay abreast of changes in the product pipeline/emerging technologies to ensure we adapt our Quality Systems to meet current and future needs.

Engages with Innovative Medicine Quality Strategy and Portfolio management to ensure achievement of Annual Strategic and Business Planning goals and objectives:

• Provide oversight and status tracking on key projects within the portfolio,

• Represent Quality Systems in financial calls representing and tracking progress.

Act as a point of contact for integrating/separating Innovative Medicine quality systems in acquisitions/divestitures.

• Work with program lead to ensure timeliness of implementation

• Partner with overall integration Quality Lead to define strategy for assessing current state Quality Systems process and technology

Maintain linkage to other Business Process Owners (ie: TranSCend) and ensure effective communications as such.

Qualifications

Education:

A minimum of a Bachelor's or equivalent University degree is required with a focus in Science, Engineering, Quality, Operations or technical/quantitative field preferred. Advanced degree preferred.

Required Knowledge, Skills and Abilities :

• 12 years of experience in Quality Management Systems and/or Operations Management in a highly regulated industry (Pharmaceutical, Medical Device or similarly regulated industry).

• Experience in strategy development and strong program management experience a must,

• Must have experience in an application deployment,

• Strong leader with the ability to establish clear strategy that can encourage others to deliver and influence to motivate change across the organization,

• Ability to influence, innovate, negotiate, and deliver business objectives,

• Consistent track record of collaboration, including the ability to work with cross-functional teams, and across complex ecosystems,

• Outstanding communications skills (including articulating product vision, inspiring teams, and presenting to senior executives).

• Experience working with Quality Systems is crucial (ie: Document Management, Change Control, Deviation and CAPA Management, etc.) at a process, platform, and execution level,

• Strong negotiation, communication, collaboration and networking skills.

• Experience leading and implementing change strategies.

• Experience leading complex projects.

• Financial Competence.

• Ability to translate complex concepts for a variety of partners required,

• Strong planning and organizational skills with a good understanding of priority setting.

• Proven track record working in a global matrix environment.

• People management experience.

• Ability to translate vision and strategy into executable outcomes

Preferred Knowledge, Skills and Abilities :

• Experience on a Quality Systems deployment integration and/or separation project team

• Previous experience with budget, resource management and capacity planning a must

• Good understanding of GxP and Computerized System Validation requirements

• Experience in leading diverse, muti-disciplinary teams (direct and indirect) and connectivity across a matrixed and diverse organization to drive alignment

• Process excellence certification (e.g. SixSigma, LEAN, or DEX green or black belt)

• Strong sector AND global approach within a manufacturing environment

• Strong collaboration and interpersonal skills

• Experience with acquisition and /or divestitures

• Compliance with the GxP, EHS and SOX requirements and guidelines, which are connected to the respected function.

• Lean Six Sigma Blackbelt certification

Other:

• This position requires up to 25% Domestic & International Travel

• This position has an estimated annual salary of $142,000- 284,000 USD$

• 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-New Jersey-Titusville

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

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Travel Yes, 25 % of the Time

Job Function Quality Systems

Req ID: 2406192499W