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Senior Project Manager, Quality Standards

1 month ago

Limerick, Limerick, Ireland Johnson & Johnson Full time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function
Project/Program Management Group

Job Sub Function
Project/Program Management

Job Category
People Leader

All Job Posting Locations:
Dublin, Ireland, Galway, Ireland, Limerick, Ireland, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland, Westport, Mayo, Ireland

Job Description
We are searching for the best talent for a Senior Project Manager, Quality (Emerging Standards and Regulations Integration) to be located at a J&J MedTech site. Remote work options may be considered on a case-by-case and if approved by the Company.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your outstanding talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.

The Senior Project Manager - Quality (Emerging Standards and Regulations Integration) will lead the assessment and implementation of major standards and regulations at J&J MedTech businesses. The work will include the assessment of standards and regulations at both newly acquired companies and within existing J&J MedTech businesses. The Senior Project Manager - Quality (Emerging Standards and Regulations Integration) will need to be able to independently evaluate standards and regulations, and may need to influence partners in the business. This leader may also need to lead contract resources.

You Will Be Responsible For

  • Develop a coordinated plan to implement standards and regulations in alignment with internal and external partners.
  • Lead the assessment and implementation of external standards and regulations.
  • Implement governance for strategic priority objectives - engage with executive sponsors and key partners, developing regular communications.
  • Lead budget planning and maintenance for projects.
  • Drive risk identification, management and plans for resolution.
  • Responsible for hiring and management of program level resources including partnering with consultant/contractor resources.
  • Inspire Change & Communication strategies.
  • Lead team meetings, with accountability for agenda & content management.
  • Responsible for presenting business related issues to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Qualifications/Requirements
  • A minimum of a B.S. degree preferably in engineering, scientific, business, or technical field.
  • Proven experience (minimum of 8 years) in the medical device or pharmaceutical industries required.
  • Confirmed quality systems experience in medical device and combination product quality systems is required.
  • Strong and progressive career in Quality/Compliance, program & portfolio management, operations, or supply chain functions.
  • Proven understanding of regulatory requirements (EU MDR, FDA, etc.) and their impact on Quality Management Systems and associated processes.
  • Outstanding written and verbal communication skills are required.
  • Strategic problem solver with strong leadership ability, interpersonal, communication, and influencing skills is required.
  • The ability to nurture a productive team-oriented environment, balance multiple assignments, and display flexibility in response to an environment with rapidly shifting priorities is strongly desired.
  • Strong technical, planning, and execution capabilities and ability to analyze, balance, and prioritize risk are required.
  • Supervisory experience is preferred.
  • Direct experience supporting FDA and global regulatory inspections is strongly preferred.
  • This position requires 10% Domestic and International travel.
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.

Johnson and Johnson is committed to providing interview processes that are inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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