QA Operations Manager, Benelux

Hiring By - Biostaffic

 BioPharma

Belgium

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
Role Overview :
You are a Qualified Person & Responsible Pharmacist and member of the QA team within the Haleon Benelux Local Operating Company (LOC).
You endorse QP delegate and RP responsibilities for Benelux Market(s) and ensure Benelux LOCs and contractors are operating in compliance with EU/National regulations (GMP/GDP/MDR/EU Cosmetics, BE/NL/LUX regulations) and Haleon Quality System.
You are in charge of the supervision of QA Operational activities related to distribution and batch release of Haleon products* in Benelux (*includes medicinal products, medical devices, cosmetics, food products and general consumer goods).
Key Responsibilities :
As QP Delegate, you will :
  • Working with the Benelux Quality Lead, ensure compliance, product quality, audit/inspection management and readiness
  • Participate to the QP-certification of medicinal products
  • Oversight and supervise (guide/support when needed) the Benelux QA Specialists in the operational activities:
    • Batch Release dossier preparation
    • Receipt, Storage and Returns
    • Local Repacking
    • Quality Complaints management
  • Ensure oversight of Benelux Logistic Service Providers (LSP) and participate to their qualification (audit, Quality Agreement, licences/authorization review)
  • Act as liaison with Haleon manufacturing sites and Contract Manufacturing Organizations (CMO) to ensure manufacturing in compliance to local registered technical details. Participate with the Quality Lead to the supplier qualification activity and the review and approval of the Technical Terms of Supply (TTS) and Quality Agreements.
  • Ensure an efficient customer verification process is in place
  • Approve and follow up Benelux Change Controls
  • Perform local review of annual Periodic Product Reviews (PPR’s).
  • Participate to the setup of Distribution Risk Assessments (DRA) for products supplied from the local warehouse to the end customers.
  • Ensure oversight and support Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS, GMP/GDP-requirements and medical devices regulation.
  • Ensure local Quality deviation investigation (Root Cause Analysis), CAPA definition and execution. Follow up the deviation and CAPA lead-times.
  • Recall & Incident management: Member of the local Product incident review Committee as appropriate and support of recall coordination when required.
  • Support the QA team with the development and maintenance of procedures and work instructions.
  • Act as Subject Matter Expert for specific Benelux GxP-processes and systems.
  • Participate to Quality Councils. Support management reviews and KPI-reporting.
  • Contribute to the Benelux Quality Plan (setup and execution).
Qualifications & Skills :
  • Certified Industrial Pharmacist / Qualified Person / Responsible Person
  • MSc in Pharmaceutical Sciences or related science
  • Good understanding of GDP and GMP, pharmaceutical regulation
  • 3+ years of experience as a practicing QP/RP
  • Analytical mind, good attention to detail and problem-solving skills within a structured process
  • Demonstratable time management skills and ability to multi-task in an ambiguous environment
  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
  • Self-motivated and resilient
  • Proven computer skills in Microsoft Office tools and familiarity with SAP (Veeva is an asset)
  • Able to work effectively in English & French (and/or Dutch)
What we offer:
  • A fast-paced organizational and business environment.
  • An opportunity to learn from a variety of healthcare products and to be exposed to both Belgian and Dutch markets and regulatory environments.
  • Hybrid@Haleon, our philosophy to hybrid work.
  • Learning and development opportunities.
  • Market-leading policies such as our 26-weeks equal parental leave.
  • Highly competitive compensation and benefits package.
  • Employee Assistance Program.
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
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.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Belgium

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Haleon
Haleon

Current Openings: 0

Our purpose is to deliver better everyday health with humanity. #HelloHaleon Community guidelines: https://haleon.global/SocialMedia
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