Quality Assurance Manager/Qualified Person

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

Quality Assurance Manager/Qualified Person 

This role is embedded in LOC (Local Operating Company) Quality CEE team and reporting to Cluster Quality Lead Poland & Ukraine.

The purpose of the job is to ensure LOC Quality processes and systems are in place for all activities carried out across the Local Business ensuring as well that they are in compliance with Haleon standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements. 

This role is responsible for overseeing both the warehouse of an importer and manufacturer, including the commercial repackaging of products. The position also manages the release of imported goods, ensuring that all necessary processes are established and maintained. Key responsibilities include safeguarding licensing compliance for warehousing and import activities, as well as managing the certification of product batches—a newly introduced aspect of the company's operations that will also cover the certification of repackaged batches.

As part of a broad team within CEE region, there are opportunities to participate in cross-country projects, fostering collaboration and professional development in a dynamic international environment.

These responsibilities include some of the following processes and systems (but not limited) to: 

• Product supply. Develop, specify and approve processes and systems that have an impact on the quality of products in line with QMS and local regulatory requirements.

• Accountable for review and approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details (in connection with local regulatory team), including Distribution Risk Assessments for products supplied from manufacturing site to market and products supplied from the Multimarket Warehouse (MMW) /local warehouse to end customer. 

• Liaison with External Supply (ES) Quality for products that are manufactured by contractors to ensure compliance to local registered technical details (in connection with local regulatory team). Accountable for review and approval of the Quality Agreement per product per ES. 

• Ensure any Third Party Supplier (3PL) providing GxP services to the LOC is audited by central audit functions, and a Quality Agreement is in place 

• Perform routine checks on validity of local GDP/ GMP Licenses held by all 3PLs and third party distributors. 

• Liaise with MMW / local Logistic Operators to make sure the mandatory 3PL CERPS QA Controls are in place and routinely controlled. 

• Receipt, Storage and Returns. Ensure LOC processes and systems in place for all activities related to receipt of stored goods, receipt of returned goods, warehousing and storage of all products (medicines, medical devices, cosmetics, food, nutritional, toothbrushes) are in compliance with Haleon QMS. 

• Work closely with supply chain organization who manages logistics associated with these activities, ensuring all any change on GxP activity is approved by QA in advance and appropriate Change Control has been delivered and approved by all involved areas.

• Qualified Person Responsibilities for imported products. To lead local batch assessment and release for distribution activities to ensure local releases for distribution are carried out efficiently, in a timely manner, and meeting relevant regulatory standards. 

• Perform all Duty of Care activities and to release the product for distribution on the local market and report result of DoC to EU QP.

• Release finished products for distribution on the market or reject batches if case of non-conformance is identified by EU QP. 

• Investigate and resolve Quality-related issues arising from the deliveries in cooperation with Area Quality Lead, Logistic Services Provider (LSPs) and supplying sites. 

• Manage temperature excursions from deliveries from supplying sites to MMW and MMW to wholesalers. 

• Issue requests to put on hold or recall the products that are suspected to be out of compliance. 

• Issue requests for additional investigation of non-conforming batches in case of deviation from registered products details (specifications) or standards. 

• Order corrective actions related to improvement of quality for imported products. 

• Perform all quality activities into CERPS and GMM as appropriate. 

• Local Repacking. Manage all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity as well as to ensure timely QA batch release of repacked orders before distribution and/or re-export. Ensure documentation of batch records including repack protocol and retention of samples, where applicable. 

• Recall & Incident management. Being part of local Incident Management Team as appropriate. 

• Collaborate with self-inspection, and other forms of evaluation to ensure that local operations are in full compliance with Haleon standards and policies, Haleon QMS, GMP, GDP and regulatory requirements for all of marketed products (medicinal products, medical devices, cosmetics, foods, others). 

We are looking for professionals with these required skills to achieve our goals:

• Complete and Satisfactory Second Level of Education in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology 

• Complete the supplementary pharmaceutical QP study (no applicable for Pharmacy education) 

• Fluent in Polish & English

• Minimum of 2 years experience within Pharmaceutical GMP manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products 

• Minimum of  5 years of Quality experience within the pharmaceutical industry, and application of Quality Systems & Quality Operations with focus on CAPA, quality incident and risk management 

• Knowledge of regulatory requirements pertaining to GMP/GDP 

• Understanding of and experience in quality assurance systems particularly in the areas of batch release, batch certification, product incidents, artwork control and performing audits 

• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook 

• Best in class problem solver, strong solution orientation, with a drive for urgency, a growth mindset, challenging status quo approach

• Being bold in moving things forward

• Team-collaborative mindset

• Focused on consumer/ shopper

• Collaborates for better impact

• Unlocks value at pace

• Focused on growing him/herself and others

Improving everyday health takes dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes:

• Career at one of the leading global healthcare companies 

• A competitive base salary

• Contract of employment

• Attractive reward package (annual bonus that reflects Haleon’s and individual’s performance & awards for outstanding performance, recognition awards for additional achievements and engagement) 

• Car or car allowance

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible

• Sports cards (Multisport)

• Family benefits (extra parental leave, caregiver’s policy) 

• Health and wellbeing programmes that take care of you physically and mentally

• Hybrid@Haleon our philosophy to hybrid work (flexible approach)

• Possibilities of development within the role and company’s structure

• Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities) 

• Supportive community and integration events 

• Modern office with creative rooms 

Location – this role is based in: Poland, Warsaw

#Li-Hybrid

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Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

 Job Posting End Date

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.
During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. 
The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. 

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.