External Manufacturing Quality Lead

6 months ago

Guelph, Canada Johnson & Johnson Full time

Description

Kenvue is currently recruiting for:
**External Manufacturing Quality Lead**

This position reports into the Manager, External Manufacturing Quality or Senior Manager, External Manufacturing Quality Manager and is based in Guelph, Canada.

**Who We Are**

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.

Travel: up to 50% in Canada and in the United States

**What You Will Do**

The External Manufacturing Quality Lead position provides overall Quality Assurance leadership in the management of contract manufacturers/affiliates engaged in the production of ingestible and topical OTC drugs, medical devices, combination products, NDA’s, cosmetics, engineered products, etc. for Kenvue. The External Manufacturing 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, interfacing with Kenvue 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. Oversight of quality systems as applicable.

**Key Responsibilities**
- 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. A mentor to junior staff.
- Provide 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 deliverables 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, ingenuity, 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 Make Q&C 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 manage and prioritize highly complex and diverse workload ensuring deliverables 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, manufacturing site documentation, 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 todrive compliance and/or efficiency.
- Drive closure of MAPs, through holistic and comprehensive engagement and negotiation with EM

**Qualifications**:
**What We Are Looking For**

**Required Qualifications**
- Education:

- A minimum of a Bachelor’s Degree (BA/BS) is required.
- A focused degree in Engineering, Chemistry, Biology, or Biological Sciences is preferred.

**Experience**:

- A minimum of 6 years of relevant work experience in a GMP environment
- Experience leading and owning investigations, CAPAs and/or CAPA action items or deliverables
- Demonstrated ability to design and implement quality and compliance improvement programs
- De

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