What we do
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.
Who We Are
Our global team is ~22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers.
Role reports to: Senior Director, Internal Make Q&C
Location: Europe/Middle East/Africa, South Africa, West Cape, Cape Town
Work Location: Fully Onsite
What you will do
The person for this role will Lead, Manage, and Implement Site Quality Systems and Plant Quality in compliance with applicable South Africa / Sub Sahara Africa regulations and Kenvue policies and standards, as well per SANS 1043, SANS 1841, ISO 9001, ISO 13485 and PICs GMP requirements. Act as the Responsible Pharmacist as contemplated under the Pharmacy Act and South African Pharmacy Council Rules.
Key Responsibilities
•Lead and Oversee Compliance of Site Quality System and Plant Quality and Processes with Kenvue Standards
•Review and Implementation of Quality Systems Elements, Regulatory & Compliance requirements and Kenvue Standards deployment
•Coordination and Monitoring of Quality System KPIs and Metrics e.g. NC, CAPA's, Global Change Control, Internal Audits and Training to ensure compliance of site with Kenvue standards and requirements
•Coordination and Monitoring of Plant Quality KPIs, BRS Right First Time, On-time releases of products and managing raw material and packaging quality issues
•External Audit / Inspection Readiness through site preparation, coordination, action plans and compiling reports for tracking progress and timely completion of actions
•Continuously Train and Develop Site Personnel to applicable GMPs and updated regulations and standards
•Manage Direct Materials and Indirect Material Suppliers
•Simplification and Optimization of Quality System processes
•Deployment of Continuous Improvement and Innovation initiatives to improve agility of the Quality organization
•Conduct Site Quality Management Review
•Oversight, review and approval of Product Quality Review reports
•Oversight of Quality Control Laboratory activities and On-Time Release of materials and finished products
•Administer or Support Administrators of various Quality Electronic Systems
•Comply with Human Resources, and Environment, Health & Safety requirements and policies
•Interact with cross-functional teams to ensure that all processes can consistently meet quality standards and product attributes and participation in multi-departmental projects
•Conduct Leadership Quality on the Shop Floor Gemba Walks
•Handle and escalate critical Quality Holds & Escalations to senior Regional Management; attend and present in Quality Review Board Meetings to ensure informed decision making; conduct Product recalls, Market withdrawals and Regulatory notifications
•Oversight of customer complaint investigation and trending
•Release Finished Product Release for all OTC products after Batch Record Review Documentation
•Connect with External Regulatory Agencies or Bodies as required for site certification and important issues
•Ensure that Quality Assurance and Manufacturing functions are in compliance with Kenvue Corporate Regulatory Compliance, South African Health Products Regulatory Authority (SAHPRA), applicable Pharmacy and business Acts (i.e. Environmental Health & Safety Act, Trade and Metrology Act, Foods Stuffs Cosmetic & Disinfectant Act) and any other relevant regulation that may be promulgated. Consults with regulatory agencies to determine documentation requirements and reviews internal documents for compliance
•Oversight of Quality Budget Expenditure, CAPEX and OPEX. Continuously realize and implement cost improvement initiatives
•Actively participate and/or lead assigned Regional Projects
Required Qualifications
Required Minimum Education: Bachelor's Degree in Pharmacy
•At least 10 years' experience in the Pharmaceutical industry, with min 3 years in a Production function and 5 years in Quality Leadership
Preferred Certifications/licenses:
•Registration with SAPC
•Eligible to act as Responsible Pharmacist in South Africa
Preferred Knowledge, Skills and Abilities:
•Software proficiency in Veeva, BPCS, Tru, Symphony, Microsoft
•Soft skills such as effective communication, teamwork, problem-solving
