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The primary responsibility of the Commercial Quality Manager (Health) is to provide leadership for excellence in Quality and Compliance of all Health products and processes within the supply/distribution chain, including embellishment. The CQM will: lead and facilitate quality continuous improvement activities; assure proper quality systems are developed to comply with current regulations such as relevant GMP and GDP; implement processes and procedures and observe/audit for compliance; establish objectives for Quality improvement within the region; provide feedback to the region on performance against relevant internal and external quality, regulatory/statutory requirements; serve as a resource for information relative to all aspects of products and process quality; facilitate the ‘right first time’ approach and implementation of new products and processes; and support and integrate continuous improvement principles within the region through proactive communication, partnering, training and education.
The CQM will fulfil the legal duties of the Qualified Person, including the release of medicinal products (both imported and manufactured within Turkey) in the market in accordance with National Law.
This position is responsible for ensuring that the region maintains compliance with applicable regulations as appropriate while also supporting and enabling the business to achieve its business objectives. The Commercial Quality Manager (Health) must be the prime business contact with Health Authorities and other external bodies, work effectively with internal parties, manufacturing sites, third parties and corporate personnel. This role comes with an initial contract period of 8 months, with the possibility of a short extension.
To manage all technical GxP issues in accordance with MoH guidelines
To perform Qualified Person release for sale of medicinal products to the market
To ensure that products are manufactured and controlled in accordance with current legislation, guidelines and their marketing authorization, batch records are approved, and they are kept in secure place within defined time period in the guidelines and can be submitted upon request by MoH
To ensure that all retain and reference samples that are proof of the suitability of batches should be kept in accordance with MoH legislation and available within reasonable time frame upon request by MoH
To ensure that controlled substances are reported to MoH as requested according to regulations
To ensure that recall is carried out in accordance with current regulations.
At least Bachelor's Degree in Chemistry, Chemical Engineering, Pharmacy or Medicine
At least 5 years’ experience in quality roles in pharmaceutical manufacturing plant or PhD degree from faculties defined above with no requirement of pharmaceutical manufacturing experience
At least 2 years' experience as QP in the pharmaceutical industry
Experience in developing and maintaining a robust QMS in a Healthcare, Pharmaceutical, or Medical Device related industry.
Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.
Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product e.g. EU GMP, EU GDP, WHO, PIC/S, ICH9 and 10, and Turkish National Legislation relating to Medicinal Products.
Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GMP/GDP.
Auditing skills, appropriate qualifications in auditing an advantage.
Quality Compliance, Change Management, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.