Johnson & Johnson Family of Companies Hiring for External Manufacturing, Quality Lead at Ontario Full Time

Vogue International, a Johnson & Johnson Company, is an innovative consumer products business that distributes cutting-edge hair care products to large retail chains around the world. These brands represent an innovative hair care business which is new to our Consumer Family of Companies and focused on the marketing, development and distribution of salon-influenced and nature-inspired hair care and other personal care products. With several strong brands among its portfolio, including OGX® and MAUI MOISTURE®, the Vogue business is the cornerstone of Johnson & Johnson Consumer’s hair care operations. Vogue International products are sold in the U.S. and in 38 countries.

The External Manufacturing (EM) Quality Specialist III position provides overall Quality Assurance leadership in the management of contract manufacturing sites engaged in the production of oral ingestible and topical OTC drugs, medical devices, combination products, nutritionals, NDA’s and/or cosmetic formulations for the J&J Consumer Sector. The EM Quality Specialist III is responsible for supporting External (Contract) Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reviewing Annual Drug Product Review reports, reporting External Manufacturer performance metrics, working with J&J business partners and providing batch release when required. This job position may represent QA on project and improvement teams by guiding setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support.

Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.

• Provides detailed or summary communication to senior cross-functional leadership on status of key initiatives and issues.
• Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.
• Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues.
• Ensure timeliness of results through independent, proactive intervention. May act as a CAPA owner or may own CAPA action items or deliverables
• Troubleshoot high risk/high complexity quality/compliance issues, using experience, resourcefulness, and creativity to provide solutions to a wide range of root causes.
• Implement quality and compliance improvement programs and initiatives. Innovate solutions to quality system gaps and participate in continuous improvement projects.
• Represent NA Make Quality on multiple, simultaneous, high-impact/ high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring quality and compliance inputs are integrated into the project objectives, and act as a QA “go-to” resource for cross-functional business partners.
• With a modest amount of daily direction and oversight from manager, prioritize highly complex and diverse workload ensuring results are on-time, accurate, and meet their intended objective.
• Independent and guided decision making authority and accountability for product disposition and compliance decisions with significant potential impact to customer service
• Review and approve compliance records, specifications, development plans, procedures, and other documents, as required by procedure.
• Responsible for revising established processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency
• Drive closure of MAPs, through holistic and comprehensive engagement and negotiation with external manufacturer (EM)

Qualifications

• University/Bachelor’s Degree required in Chemical Engineering, Biology or Science related field is preferred.
• A minimum of 4 years of related work experience required
• Experience leading and owning investigations, CAPAs and/or CAPA action items or deliverables Required
• Experience troubleshooting high risk/high complexity quality/compliance issues Required
• Experience supporting External (Contract) Manufacturing sites from a quality perspective Preferred
• Experience with SAP, ETQ and Trackwise Preferred

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

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.

Primary Location

United States-New Jersey-Skillman-199 Grandview Road

Other Locations

North America-United States-Florida-Clearwater, North America-Canada-Ontario

Organization

Vogue International LLC (6232)

Job Function

Quality

Requisition ID

2206000763W