Quality Manager - Pharma Channel FRBNL

Reckitt Benckiser LLC; Massy; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading healthcare company located in Massy is seeking a Quality Manager to lead compliance in Health products. The successful candidate will ensure quality management systems meet regulatory standards, lead continuous improvement projects, and support a culture of quality and safety within the organization. Candidates with at least 5 years of relevant experience and fluency in both French and English are encouraged to apply. Benefits include comprehensive wellbeing programs and performance-based incentives.

Prestations

Parental benefits

Employee Assistance Program

Life insurance

Qualifications

• At least 5 years’ experience in quality compliance in Healthcare or Pharmaceutical industry.
• Experience developing a robust QMS in related fields.
• Understanding of GMP and GDP requirements.

Responsabilités

• Lead the local Quality Management System to ensure compliant products.
• Provider leadership on quality initiatives.
• Maintain a state of inspection readiness for the QMS.

Connaissances

Quality compliance

Auditing skills

Interpersonal skills

Change management

Fluency in French

Fluency in English

Description du poste

Quality Manager - Pharma Channel FRBNL

City: Massy

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About the role

The primary responsibility of the 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 QM 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.

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 Quality Manager (Health) must work effectively with internal parties, manufacturing sites, third parties, external bodies and corporate personnel.

Your responsibilities

• Responsible for supporting the GM’s and their management teams to enable them to develop and implement the local Quality Management System (QMS) to ensure fully compliant products.
• Provide leadership on continuous improvement projects, quality initiatives, etc. as established by corporate Quality Management.
• Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global BMS & associated policies, relevant codes of practice and GDP.
• Ensure that the QMS is maintained in a state of inspection readiness.
• Ensure a system is in place to manage local embellishment, re-pack, and co-packing work to meet all regulatory requirements.
• Change Management - Ensure a robust and effective change control system is in place to ensure business changes are effectively managed.
• Training – Ensure a training system for the business is in place and provide training on the local QMS.
• Issue Management - Investigate quality issues (Non-conformances) and failures (CEP Events) and apply Corrective and Preventive Actions (CAPA) to prevent recurrence. Advice regarding CAPA necessary at regional quality level for items not under local control. Ensure that improvements to products and procedures can be identified and fixed.
• Audit/Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. Audit should cover all aspects of the BMS and local QMS to ensure compliance. Ensure a routine review program and audits are in place for Third Party providers
• Document Management – Maintain a document control system for the local QMS. Perform reviews and approve business procedures & Technical Agreements.
• Product Recall - as per the Critical Quality Events and Product Recall procedure establish and communicate responsibilities. Conduct mock recall exercises to confirm adequacy of the local recall procedure.
• Maintain a Fit-For-Purpose QMS: Report level of compliance of local QMS versus BMS, Policies and GDP regularly to GM’s, Regional SVP’s, Area EVP’s (with Supply SVPs on copy) using monthly reports and Management Review and drive closure of gaps to maintain compliance.
• Complaints – Support Consumer Relations and Customer Services with complaint handling procedures and systems to ensure effective feedback to the business and the factory to reduce complaints.
• Detailing – ensure the compliance and respect to the Medical reps Charte, support development and continuous improvement of the APM team
• PQR – oversight on PQR, participate to the review of PQR
• Responsible for initial compliance assessment and approval of Distributors & Embellishers handling Health products.
• Ensure Technical Agreements (TAs) are in place for all Distributors & Embellishers – ensure all quality expectations are included (e.g. change management, product handling, product release, responsibilities).
• Work with regional and Supply Quality teams to ensure implementation of appropriate controls to ensure consistent quality of the products
• Co-ordinate and host external inspections by External Authorities, third parties and RB.
• Co-ordinate follow ups and responses after external inspections.
• Take over the Responsible Pharmacist (RP) responsibility (according to French Public Health code), in case of absence of RP and after formal request from the RP and formal acceptance from the Quality Manager.

The experience we're looking for

• At least 5 years’ experience working in a quality compliance function in Healthcare, Pharmaceutical, or Medical Device related 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, CFR 21 Part 210/211.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in French and English is mandatory.

What we offer

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.

Equality

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.