Emq Lead

**EMQ Lead**-2307010262W

Description

Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for a External Manufacturing Quality Lead. This position reports into the Quality Manager, External Manufacturing Quality and is based in Guelph or Markham Canada.

**Who We Are**

At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

Join us in shaping our future-and yours. Watch us here:
**What will you do?**

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 Kenvue 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 Kenvue 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.

**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.
- Provides overview or detailed communications to Q&C and 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.
- Independently manage and prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.
- Review and approve compliance records, specifications, development plans, procedures, and other documents, as required by procedure.
- Supports and may lead 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.
- Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions and recommendations in case of QRB and Escalations.

Qualifications

**Qualifications**

**Required**:

- A minimum of a Bachelor’s Degree is required
- A minimum of 4 years of GMP experience (or 4 years of experience in a QA role, with plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production
- Proven ability to lead and influence others within product teams with excellent communication and presentation skills.
- Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries, and influencing without authority required.
- Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
- Strong communication (verbal & written) and interpersonal skills, s