Johnson & Johnson Careers
Senior Manager, Quality Systems
Santa Ana, California
Requisition ID: 5703180702
Johnson and Johnson Family of Companies is recruiting for a Senior Manager Quality Systems, to be located in Santa Ana, CA to support our Johnson and Johnson Vision business.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.
You, the Senior Manager Quality Systems, will ensure successful integration, maintenance, and continuous improvement of the Quality System’s global document control and records management processes in a customer-centric manner. Ensure document control processes that support product lifecycle management maintain compliance while supporting timely implementation to support business and customer needs. This position interacts directly with both external and internal auditors as the Subject Matter expert and ensures that the company’s global change control process maintains compliance with internal and external standards and regulations. Will lead and develop staff that perform document processing, PLM system work flow management and training, quality representative role in non-product software validations and assessing IT changes impacting business systems/software, and project management while collaborating cross-functionally to meet business and customer needs.
You, the Senior Manager Quality Systems, will:
- Identify and assess resource needs and skills that support the vision and values of JJSV. Hire, train, manage and develop Quality professionals to proactively support business needs while supporting career aspirations.
- Contribute to the development and optimization of operational policies and procedures that affect personnel within the assigned organizational unit and cross functional affected areas.
- Monitor daily work operations and provide direction and guidance to staff to achieve unit or project goals. Interact with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
- Use data driven business cases for project and resource justifications. Optimize workflow processes for quality system documentation and archiving of records.
- Ensure compliance with company policies and procedures (e.g. compliance with FDA and applicable international regulations etc.).
- Act as Subject Matter Expert in document/change control, PLM systems, and support internal and external audits within the area.
- Provide input to Quality Management Review and supporting processes.
- This position supports the integration and harmonization of sites processes and serves as the PLM system business owner.
- This position has expanded global responsibilities working with multiple locations to develop, implement, continually improve, and maintain a comprehensive document control system for all types of quality records.
- A Bachelor’s degree is required; a Master’s degree is preferred.
- A minimum of 8- 10 years of direct experience in a quality and/or compliance role in medical devices industry.
- Working knowledge of medical device quality system processes, e.g., 21 CFR Part 820, ISO 13485, CMDR, MDD/ EU MDR, MHLW; related labeling and packaging standards, and 21 CFR Part 11 is required.
- Hands-on experience using PLM software systems, e.g.., Agile
- A minimum of 3 years of people management experience is required.
- Ophthalmology product knowledge desired.
- Proven leadership skills demonstrated thru building and engaging a high performing team – can follow as well as lead.
- Hands-on experience of validating non-product software (i.e., CSV/SDLC).
- This candidate should have a proven track record implementing Quality System improvement to meet compliance and overall business goals.
- Demonstrated expertise in interpretation and pragmatic application of QA standards is preferred. Initiative in innovative approaches to QA solutions and applications in a fast-paced changing global business environment are preferred
- Dedicated to excellence in teamwork and collaboration cross functionally and within Quality & Compliance teams.
- Strong analytical skills, mastery of written and verbal communication skills, high energy level, driven to succeed, excellent technical skills and critical thinking, and project management skills are required.
- Delivered improvements in efficiency, cost, compliance and excellence through others.
- Hands-on experience in managing and driving CAPAs, including use of root cause analysis tools.
- This position will be located in Santa Ana, CA and may require up to 10% domestic and/or international travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana
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