Johnson & Johnson is currently recruiting for a Senior Quality System Specialist! This position will be located in Toronto, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
This position is responsible for the support/ownership of the following Quality System Functions: Controlled Document Management, Records Management, GxP Training, Corrective Action/Preventative Action (CAPA), Deviation/Non-conformance Management, Internal/External Audit, and Change Control. Additionally, this role is responsible for data analytics and management that will help support the broader Janssen Canada commercial organization.
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Major Responsibilities:
• Reviews and challenges Commercial Quality (CQ) processes to ensure continuous process improvements and lead associated implementation
• Training, onboarding, and oversight of Vendor work
• Super User for Document Management system TruVault including Community of Practice attendance
• Training System Business Learning Administrator including issue resolution and escalation
• SME for Document Management and Training; including procedural ownership and perform assessment for any new or revised process changes
• Provides audit readiness and ongoing audit support including any corrective actions
• Support/back up Quality Systems elements such as nonconformance, change control, internal audit including reviewing and approving quality records
• Develops/prepares and deploys training materials and programs to meet CQ organizational needs
• Acts as liaison for segment and function specific training
• Manage Global Quality Manual binder, and maintain the procedures list
• Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions
• Collaborates with internal partners to ensure the consistency and efficiency of CQ training curricula and training systems
• Communicates changes to or the introduction of new controlled documents along with any required downstream document management and training activities
• Coaches/trains users of the document and training quality system processes
• Supports the implementation of various new/updated processes and tools
• Maintains current with training requirements related to any specialized role in the electronic systems used in training and document management (e.g. TruVault, Summit)
• Performs validation tests for Document and Learning Management Systems enhancement
• Manage Workbook Validation process, and provide support in Janssen Canada
• Track progress of quality system activities and follow up with issue owners to ensure completeness and suitability of actions prior to file closure. Ensures timely closure of actions
• Review trending results with management on a monthly basis for roll up to CAPA Review Board
• Assess health authority and internal standards/SOP updates and impact on processes/systems
• Act as Record Coordinator for CQ Canada as a liaison between the department and the Records and Information Management (RIM) program to support compliance with RIM requirements
• Oversight of job description/summary or experience maintenance in applicable repository
• Other duties and functions within Quality department as required
Qualifications
Education:
A minimum of a Bachelor's or equivalent University degree
Required:
• Minimum 3-5 years in quality systems role with current GxP experience
• Experience in a pharmaceutical importing/distributing environment, with preferred experience in a manufacturing environment.
Core/Technical competency requirements:
• Effective strategic thinking capabilities, driven by sense of urgency and focused on results
• Strong technical proficiencies in multiple systems including (but not limited to): SAP/ ETS Trackwise/Salesforce/MS Office/Learning Management tools and able to provide support to other users
• Working knowledge of Record Management, and Legal Hold
• Strong ability to negotiate and influence key stakeholders (internal & external)
• Demonstrates agility and adaptability in learning new technologies and business processes
• Excellent communication (verbal and written) and strong interpersonal skills
• Demonstrated sound judgment in dealing with risk on compliance matters
• Well defined problem solving and analytical skills
• Manage multiple priorities including owning and balancing project management in conjunction with daily work
• Superior attention to accuracy and details
• Ability to work and collaborate within a matrix environment
• Ability to work independently and in cross-functional team settings
• Understanding of validation requirements
• Promotes and uses the contribution of people with diverse ideas, perspectives and backgrounds
Other:
This position may require up to 10% domestic travel.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]