Johnson & Johnson Careers

Manager, Bioresearch Quality and Compliance (BRQC)

Irvine, California
Quality (Generalist)

Job Description

Requisition ID: 0538180503

Johnson & Johnson's Family of Companies is recruiting for a Manager, Bioresearch Quality and Compliance (BRQC) to be located in Irvine, CA to support our Cardiovascular and Specialty Solutions (CSS) business. The headquarters houses state of the art R&D facilities and is a flagship campus for Workplace Innovation. CSS includes Acclarent, ASP, Biosense Webster, CERENOVUS and Mentor which are all part of the Medical Device family of companies for Johnson & Johnson .

Biosense Webster, Inc. is the global leader in the science of heart rhythm disorders. The company developed the first real-time, 3D cardiac mapping and navigation technology, and the first electrophysiology catheter.

CERENOVUS is a global leader in neurovascular care. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

Mentor Worldwide, LLC is a leader in the global breast-aesthetics industry as a developer, manufacturer and marketer of innovative products for surgical breast augmentation and breast reconstruction.

You, The Manager, Bioresearch Quality and Compliance (BRQC)will:

• Provide Quality Assurance (QA) oversight of Clinical and Pre-Clinical Programs.

• Serve as a subject matter expert for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and, in general, serve as the GCP/GLP Subject Matter Expert for Clinical/Pre-Clinical R&D Project Teams.

• Conducts audits and assessments of clinical investigational sites, external service providers such as clinical research organizations, institutional review boards (as appropriate), and pre-clinical sites, including ensuring the effectiveness of their Quality Assurance Unit.

• Conducts internal audits of Clinical/Pre-Clinical R&D, including study documentation, e.g. Clinical Study Reports, Trial Master Files.

• Support Health Authority and J&J Regulatory Compliance Inspections; partner with CSS Q&C and Johnson & Johnson Regulatory Compliance organizations to manage and support external inspection and ensure inspection readiness for bioresearch programs. 

• Collaborate with Clinical/Pre-Clinical R&D to ensure that investigational sites, CROs and internal organizations are ready for third party inspections.

• Report to and work in close collaboration with the Director, BRQC CSS to develop and implement effective GCP and GLP quality programs across the CSS Franchise. 

  • A minimum of a Bachelor’s degree is required 
  • A minimum of 6 years of business experience is required 
  • A thorough understanding and experience with the application of Good Clinical Practice (GCP) is required. 
  • Experience working in the Medical Device or Pharmaceutical industry is required.
  • Experience working in a R&D/Clinical Trials/Clinical QA environment is highly preferred.
  • Previous experience with quality control or quality assurance activities is required. 
  • Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.) is preferred. 
  • Ability to effectively negotiate with and influence project teams is preferred.
  • Strong verbal and written communication skills are required.
  • This position will be located in Irvine, CA and may require up to 25% domestic and/or international travel.

Primary Location
United States-California-Irvine
Biosense Webster Inc. (6010)
Job Function
Quality (Generalist)
Requisition ID