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Quality

Data Integrity lead, Advance Therapies

  • Título Data Integrity lead, Advance Therapies
  • Função Quality
  • Sub função Quality Documentation
  • Categoria Senior Analyst, Quality Documentation (P6)
  • Local Raritan, New Jersey, United States
  • Postado
  • ID obrigatória 2406186685W
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Descrição

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Data Integrity Lead in Raritan, NJ!

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/.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The Data Integrity Lead will provide site level support for sustainable and effective Data Integrity controls and measures as part of the quality management framework.

Key Responsibilities:

  • Accountable for compliance to the Quality Systems procedures and policies.
  • Design and implement data control strategy at the Raritan site.
  • Act as the Subject Matter Expert on Data Integrity including Good Documentation Practices and drive compliance efforts.
  • Maintenance and monitoring of data integrity at the Raritan site.
  • Enable and empower Critical Thinking & Risk Management at Raritan site to ensure active risk management, taking all aspects of patients’ safety & product quality into account.
  • Support internal and external audits, inspections, pre-inspection readiness, certifications, trainings, tracking, and trending activities.
  • Work closely with management to propose/complete improvements activities.
  • Represent the department in interdepartmental meetings in support of process improvement initiatives.
  • Demonstrate ability to respond swiftly to departmental and interdepartmental needs and requests.
  • Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
  • Other duties will be assigned, as needed.

Qualificações

Education:

  • Minimum of a Bachelor’s or equivalent in Biology, Engineering, Science, or equivalent technical subject area is required

Experience and Skills:

Required:

  • A minimum of five (5) years of experience in Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry, across various roles.
  • Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.
  • Ability to work on complex issues with minimal direction and think analytically.

Preferred:

  • Experience with Quality systems, auditing or compliance.
  • Project Management skills.

Other:

  • Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice.
  • Requires up to 10% domestic travel.
  • The salary for this position is anticipated to be between $90,000 to $135,000

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

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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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