The Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Director, CSS BRQC, in Irvine, CA.
Cardiovascular Specialty Solutions Group (CSS) Group is combining ASP, Acclarent, Biosense Webster and Mentor into a single business unit, single global management board, single P&L.
One geographic Medical Device hub in Irvine will allow for critical mass and geographic efficiencies, including an enhanced ability to attract and develop talent and drive product portfolio to accelerate innovation.
CA Companies that make up CSS:
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat.
Advanced Sterilization Products (ASP) truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
The Director, CSS BRQC is responsible for leading the Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) quality activities across the CSS Group of Companies and ensuring that all program and functions associated with GCP and GLP comply with company standards, Health Authority guidelines and regulations.
• The position has reach across all operating companies in CSS and ensures the establishment, alignment and execution of Enterprise and Medical Device policies, standards and procedures across CSS.
• The position has a key responsibility in implementing a Clinical/Pre-Clinical Quality Management System that not only fits in seamlessly with MD Segments strategies and policies, but also matches the development of the industry and regulatory demands for clinical and pre-clinical regulations.
• The position reinforces the message that quality and compliance have a high company priority.
• Talent and people development are critical factors for the success of this role as well as championing diversity and inclusion and the tenets of our CREDO.
• The position will also: Work in close collaboration with the Head, MD BRQC and other MD BRQC key associates to develop and implement effective GCP and GLP quality programs across MD.
• Work in close collaboration with the VP CSS Q&C and associated Q&C leadership team to ensure alignment of the BRQC programs with the overall CSS Q&C QMS.
• Partner with CSS business partners to identify their BRQC needs for successful execution of their innovation portfolio.
• Establish routine presentations of compliance trends and metrics to CSS business partners and help champion organizational performance and improvement measures to drive the success of clinical and preclinical programs.
• Maintain state-of-the-art compliance knowledge and a high quality profile inside and outside of the company.
• Leverage the services of the Enterprise BRQC Cross-Segments organization to ensure successful execution of CSS programs.
• Serve as a subject matter expert for GCP and GLP.
The major responsibilities of this role include:
• Ensure effective implementation of BRQC activities in support of business partner needs
• Providing Q&C Oversight of GCP and GLP Programs: Develop Q&C oversight plans.
• Perform assessments if internal GCP and GLP QMS.
• Execute audits and assessments of clinical investigational sites, clinical research organization, and institutional review boards.
• Execute audits and assessments of pre-clinical sites, including ensuring the effectiveness of their Quality Assurance Unit.
• Supporting Health Authority and J&J Regulatory Compliance Inspections: Partner with CSS Q&C organization to manage and support external inspection.
• Partner with CSS Q&C and business partners to ensure inspection readiness for bioresearch programs.
• Ensure timely escalation of critical issues arising from external inspections.
• Maintaining Awareness of Regulations and Regulatory Trends: Monitor new regulatory legislation or guidelines which have direct impact on CSS (and MD) GCP and GLP QMS and practices and develop internal BRQC response, as appropriate.
• Identify external collaborations that can benefit CSS (and MD).
• Participate on those collaborations in alignment with guidelines established by the Head, BRQC Risk.
• Directly accountable for developing and training staff (will manage a small group of BRQC associates).
• Manage staffing decisions: hiring, termination and promotion. Evaluate performance of associates and recommend compensation changes.
• Plan development opportunities to increase efficiency, encourage job satisfaction and personal growth.
• Assessing and Resourcing BRQC Capability in Support of Business Partner Requirements: Be an integral part of business partner strategy and business planning processes. Identify BRQC capabilities required to support strategies.
• Management and External Collaborations.
The qualifications and requirements for this role include:
• A minimum of a Bachelor’s degree is required.
• A master’s degree, or other advanced degree in a related field, is desired.
• A minimum of 10 experience in the medical device (or pharmaceutical) design and development industry.
• Requires a thorough knowledge of GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and proficient quality evaluation techniques.
• Strong leadership and collaboration is required.
• A proven track record of leading and developing people is required.
• Highly committed to quality is required.
• Flexibility and persistence is required.
• Excellent interpersonal , written and verbal communication skills are required.
• Good conflict handling/negotiation skills are required.
• Problem solving skills are required.
• The ability to establish priorities and delegate responsibilities is required.
• This position is located in Irvine, CA and will require travel.
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