Quality & Compliance Lead

2 weeks ago

Guelph, Canada Kenvue Full time

**QUALITY AND COMPLIANCE LEAD**-2307004369W

Description

Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for a Quality & Compliance Lead. This position reports into the Quality Manager, External Manufacturing Quality and is based in Guelph, 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 Quality & Compliance Lead position provides overall Quality Assurance Leadership in the management of contract manufacturing sites engaged in the manufacturing, packaging, controlling and handling J&J products fully understand and meet J&J Consumer quality and compliance expectations. The NA EM product portfolio consists of both oral ingestible and topical OTC drugs, combination products, NDA’s, cosmetics, engineered products, etc for the Kenvue Consumer Sector. This position provides risk-based QA direction, perspective and support to a range of technical, compliance and business issues pertinent to EM products, processes, Quality programs and activities. This is a position within the EM Quality unit, with input to the development of strategies, goals, and initiatives, with the authority and responsibility to execute their effective deployment. The Quality & Compliance 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 Kenvue business partners and providing batch record release when required.

This position may represent QA on projects and improvement teams by guiding and setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support.

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

**Required**:

- A minimum of a Bachelor’s Degree (BA/BS)
- 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, coll

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