Senior Quality Systems Specialist

3 weeks ago


New York, New York, United States Johnson and Johnson Full time

Job Summary:
Johnson & Johnson is seeking a highly skilled Senior Quality Systems Specialist to join our team. As a key member of our Quality Systems group, you will be responsible for ensuring the highest quality standards in our cell therapy products. This is an exciting opportunity to work with a leading healthcare company and contribute to the development of innovative solutions that positively impact patients' lives.

Key Responsibilities:
• Provide support and guidance for Quality Systems, including document management and metrics reporting.
• Ensure compliance to Quality Systems procedures and policies.
• Actively participate in global super user network meetings and communicate relevant information to the team/site.
• Review a wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, Forms.
• Drive alignment and efficiencies between global and local processes.
• Provide quality input on quality systems related issues and represent department in meetings.
• Coordinate and conduct Quality Systems Review meetings.
• Support internal and external audits, inspections, pre-inspection readiness, certifications, tracking, and trending activities.
• Work closely with management and various team members to propose and complete improvements activities.
• Ability to respond swiftly to departmental and interdepartmental requests.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.

Requirements:
• Minimum of a Bachelor's degree in a relevant field, such as Biology, Engineering, Science, or equivalent technical subject area.
• A minimum of four (4) years of experience in Quality Systems, Quality Assurance, Quality Control, Validation, or Engineering in the 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.

What We Offer:
• Competitive salary range: $76,000-$121,900.
• Performance-based bonus program.
• Comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Retirement plan and savings plan (401(k)).
• Generous time-off benefits, including vacation, sick time, holiday pay, and personal and family time.



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