Data Integrity Lead

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Data Integrity Lead! This position will be located 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.


* Train, develop, coach and mentor employees.


* 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.

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.


* Prior experience in leading direct reports.


* 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 abil...