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Job Description - Regional Quality Systems Lead (2407022687W)Regional Quality Systems Lead - 2407022687W
DescriptionKenvue is currently recruiting for:
Regional Quality System LeadThis position reports into the Head of Q&C EMEA and is based in South Africa. Please note that this is a fixed-term contract.
What You Will DoServe as a dedicated Quality System representative and act as a One Quality Voice across the Q&C Franchises, be the primary quality systems contact for them. Provide strategic and tactical insights into regulatory compliance strategies. Focuses on technical issues relative to interpretation of policies, compliance, and current industry standard. Contributes significantly to the ongoing development of new procedures, techniques, and departmental guidelines.
As the lead of the regional Quality Systems team, provide strategic management oversight and leadership to the regional Quality Systems organization. Responsible for the development of all employees within the department by supporting management development and training to meet current and future business needs. Provide an environment which encourages the company's values, commitment to equal employment opportunity and the value of a diverse workforce.Be the E2E Quality system manager, responsible to transform the regional Quality Systems processes to be ready for our future and ensuring all systems are deployed consistently throughout the region, ensuring the systems are fit for purpose and functioning efficiently and effectively.Partner with the Quality Systems Global COE as well as regional functions such as R&D, Regulatory, Compliance, Supply Chain, etc. to drive improvements in process and metrics.Assures Regional QS & Compliance metrics remain green. Drive regional Corrective and Preventive actions to assure our process continues to improve and move our compliance KPIs to be fully automated and digital.Lead the strategy and tactics of compliance with all major regulations and guidance (EU pharmaceuticals, Herbals, Food Supplement, Cosmetics, Controlled Substances), maintain up-to-date knowledge of current and proposed rules and best practices acting as a regional SME as appropriate.Create and participate in the network internally with colleagues in other regions to obtain and exchange news and changes to regulations and requirements applicable for the products in the region.Interact with external partners (Health Authorities, industry groups and associations) to evaluate proposed changes and impact on EU product portfolio and participate in providing feedback.Feed/lead the Regulatory Intelligence governance in the region, who is responsible for evaluating and implementing new or revised requirements and regulation.Be the lead and act as PMO, act as an end-to-end connector with other Q&C functions for complex compliance projects, incl create structure, follow up on activities and present to stakeholders on progress.Key ResponsibilitiesDrive quality systems improvements Regionally. Coordinate with stakeholders throughout the Region and across the other Regional Quality Systems teams to drive substantial improvements in the process and execution. Shape the Global QS processes.Drive the understanding and capabilities of our Quality Systems in the region.Oversees delegation of tasks and projects to staff. Reviews progress reports and suggests resource allocation as necessary. Prepares and manages department budget. Manages the implementation and administration of quality management systems in accordance with applicable standards.Takes necessary actions in conjunction with the regional leadership team to assure regional metrics are green. Examines results from management reviews, third-party inspections and internal audits and approves proposed corrective actions.Assures the capabilities and talent development within the Regional Quality Systems team.Lead the strategy and tactics for compliance with all major regulations and guidance's incl interacting with internal and external partners to evaluate the impact on the EU product portfolio and participate in feedback.Lead and act as PMO for complex compliance projects.Support global and regional product alignment in Q&C across regions & functions for escalations and field actions.Q&C review and approval of investigations, CAPA or change controls.Q&C review and approval of procedures and instructions.QualificationsWhat We Are Looking ForRequired Qualifications
Minimum bachelor's degree in a science-related discipline is required, Masters preferred.Good business acumen and experience with setting and implementing strategies. Financial acumen is a plus.Strong operational knowledge of Quality systems and processes.Proven program and or project management.Minimum 7 years of experience in Q&C Pharmaceutical/Fast Moving Consumer Goods (FMCG) or relevant experience is required.Required Knowledge, Skills and AbilitiesExperience of the overall product development process, technical transfers, and process validation is required.Ability to collaborate with cross-functional teams to deliver results and ability to collaborate in a matrixed environment.Expert knowledge of applicable regulatory requirements (cGxPs) governing various product classification types (OTC/OTC Monograph, Herbal Medicines, Medical Devices, Food Supplement, Cosmetic).Ability to work and make decisions independently and on multiple projects.Ability to engage and align with other diverse and dispersed organizations and functions.Excellent knowledge of English is required and proficiencies in Microsoft Office applications.Proactive strategic thinker.Highly committed to quality.Flexible and persistent.Good people management skills, with the ability to select and motivate professional colleagues.Ability to independently plan, organize, coordinate, manage, and execute assigned tasks.Excellent communicator, interpersonal skills, and diplomacy.What's In It For YouPaid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!Learning & Development OpportunitiesEmployee Resource GroupsKenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary LocationEurope/Middle East/Africa-South Africa-Western Cape-Cape Town
Kenvue is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability and Equal Employment Opportunity Posters GINA Supplement.
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