Johnson & Johnson’s Medical Device Companies, part of the J&J Family of companies, is recruiting for a Manager, Clinical Compliance (WW – Quality Systems Leader) located in Irvine, CA; Raynham, MA; West Chester, PA; Somerville, NJ; or Cincinnati, OH; or Warsaw, IN, or UK, Scotland
Johnson and Johnson Medical Device Companies
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Under the supervision of the WW Clinical Quality Control and US Resource Management Director, this position is responsible for the following:
- Develop Quality Control Plans and oversee/perform implementation of quality control activities for assigned projects according to committed timelines.
- Conduct Quality Control activities which include, but are not limited to the following:
- Quality reviews of clinical trial protocols and associated documentation (including, but Informed Consent Documents, CRFs, Clinical Study Reports etc.), as appropriate, to ensure compliance with relevant standards/regulations.
- Review of Trial Master File to ensure accuracy and completeness of the documentation.
- Support process improvements and review of procedures (SOP) updates as needed.
- Independently perform and/or oversee the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
- Support the preparation, conduct and response to internal and external audits/inspections.
- Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review and communicate trends with Clinical Trial Core teams.
- Identify problems through analysis of project performance metrics and recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits.
- Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical Team, as applicable, to resolve any identified issues/problems.
- Participate in FDA BIMO audit preparation and execution.
- Participate in Clinical Trial/Study Core Team meetings, as required.
- Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
- Collaborate with functional groups including, but not limited to BRQC and complaint handling groups to ensure Clinical R&D adherence to company policies and regulations.
- Participate in departmental initiatives across the Clinical organization aimed at improving process and efficiency, in particular for the improvement of local processes.
- Participate in project management meetings and provide an overview of clinical quality and workload as needed.
- Generally serves as the GCP Subject Matter Expert for Clinical Project Teams.
- A minimum of a Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline.
- A minimum of 8 years of experience in Quality Assurance in the Medical Device Regulated industry is required. A minimum of 3 years in the R&D/Clinical Trials environment is required.
- A minimum of 2 years supervisory experience is preferred.
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Strategic & tactical Clinical and Business knowledge to guide the organization in regulatory inspections is required. Strong communication, organizational and interpersonal skills are required.
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is an asset. Ability to effectively negotiate and influence upper management, affiliates and Regulatory Agencies to ensure that regulatory and business needs are met. Ability to manage and influence external service providers.
- A minimum of 2 years of Clinical Quality Control/Assurance experience is required, Medical Device and Pharma and/or CRO monitoring experience is preferred.
- This position has 20% domestic travel with possibility for international travel and will be based in Irvine, CA; Raynham, MA; West Chester, PA; Somerville, NJ; or Cincinnati, OH; or Warsaw, IN, or UK, Scotland.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Europe/Middle East/Africa-United Kingdom-Scotland, North America-United States-New Jersey-Somerville, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-Massachusetts-Raynham
Medical Device Business Services, Inc (6029)