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

Johnson & Johnson Inc., is one of the world’s largest consumer health and personal care products company. Our consumer companies produce many of the world’s most trusted brands, among them JOHNSON’S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

The External Manufacturing (EM) Quality Lead 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, nutritional, or cosmetic formulations for the J&J Consumer Sector. The EM Quality Lead is responsible for supporting 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 Contract 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 setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support. The EM Quality Lead is a Subject Matter Expert (SME) for quality assurance processes, procedures, and activities and is required to remain current on assigned quality system training and seek out training and knowledge in adjacent areas.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:
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 be assigned as QA lead resource for a CAPA

Troubleshoot high risk/high complexity quality/compliance issues, using experience, resourcefulness, and creativity to provide solutions to a wide range of root causes.

Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects.

Represent NA Source 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.

Independently lead and prioritize highly complex and diverse workload ensuring results are on-time, accurate, and meet their intended objective.

Independent 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.

Leads the development and introduction of new 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 EM.

Qualifications

Required:
A minimum of a Bachelor’s Degree or higher

A minimum 6 years of relevant work experience

Experience leading and owning investigations, CAPAs and/or CAPA action items or deliverables

Ability to design and implement quality and compliance improvement programs and initiatives.

Experience troubleshooting high risk/high complexity quality/compliance issues

Collaborative and successful at establishing relationships with internal and external partners

Thrives in fast-paced environments, able to independently lead and prioritize highly complex and diverse workload ensuring results are on-time, accurate, and meet their intended objective

Preferred:
Experience supporting External (Contract) Manufacturing sites from a quality perspective

Experience with SAP and Trackwise

Up to 15% travel (domestic and international) may be required.

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.

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 full 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.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Primary Location

Canada-Ontario-Guelph-890 Woodlawn Road West

Other Locations

North America-Canada-Ontario-Markham

Organization

Johnson & Johnson Inc. (7695)

Job Function

Quality

Requisition ID

2206020595W