Johnson & Johnson Careers
Manager, Bioresearch Quality and Compliance (BRQC)
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.
Biosense Webster Inc. (6010)