Quality & Compliance Manager Job in Kenya

Quality & Compliance Manager

Job Function

Lead the quality and compliance function, and its implementation across the organization.
Ensure proper internal controls are in place to mitigate against quality & compliance risks by independently assessing the control environment.
Work in collaboration with the Managing Director and management team to promote a value-based compliance culture through communication and training initiatives.
As the Risk Champion, support the business to proactively identify and manage risks in all aspects of the business unit’s strategy and operations,
Advise the management team in the business on risks associated with emerging business strategies and pragmatic options for risk mitigation.

Key performance areas:

Quality Assurance

Accountable and responsible for the company’s Quality Management System
Oversee self-inspections of Surgipharm Limited facilities – Nivina Towers, Kings Business Park and Surgipharm Limited Mombasa Branch.
Ensure third-party qualification and oversight.
Develop and review Quality documents including SOPs, GDP deviations, validation reports etc.
Observe and comply with the Company Standard Operating Procedures (SOPs).
Observe and comply with WHO, Local and relevant regulatory standards set on Good Distribution Practices and Good Storage Practices (GDP & GSP).
Observe and comply with Health and Safety Requirements of Kenya and compliance with International Standards.
Act as a backup in the absence of the QA Officer for receipt & release of pharmaceutical products as per advice from Principal Companies
Create and deliver quality related internal trainings related to GDP.
Ensure final disposition for returned, recalled, and rejected products and responsibility to accept returns into saleable stock in lieu of warehouse manager.
Ensure third-party qualification and oversight.
Coordinate product recalls and handle technical complaints with the help of the warehouse manager, branch manager Mombasa and regulatory affairs manager.
Report metrics and trends of product complaint program and other quality systems as assigned.
Participate in compliance processes, procedures, audits and CAPAs.

Compliance

Ensure annual ABAC certification and conflict of interest declaration is undertaken by staff.
Drive accountability throughout the organisation toward greater business transparency.
Ensure and effective Compliance and whistle-blowing culture & programme.
Partner with Management team to proactively assess and manage risks in a way that enables the organization to deliver sustainable business growth.
Accountable for ensuring proper internal controls are in place by independently assessing the compliance framework.
Report all major or critical audit findings/non-compliance (from internal, national authority, customers and principal audits) to the head of the business and Imperial central team as soon as its identified.
Coordinate and interact with all other staff involved in risk identification and management at the operation and interface with the relevant functional risk owners to obtain risk information and/ or assistance.
Ensure principal specific requirements (contracts, code of practice, quality agreements) are complied with, in including these in written controls
Custodian of the business risk register.
Ensure effective Risk Management Committee meetings are undertaken per agreed frequency and agenda.

Nature of position

Qualifications required:

Bachelor’s Degree or equivalent.
Diploma holders with more than 5 years relevant work experience will be considered.
4 – 6 years of relevant work experience in the pharmaceutical industry
Audit/ risk management experience.
Quality Management Systems/Internal Audit Auditor certification will be an added advantage.
Pharmaceutical license is preferred.