Breda, Netherlands

Senior Manager Quality Europe

Based in Breda, Netherlands

Competitive salary, benefits, and bonus

If you are a Pharmaceutical Quality Specialist with outstanding leadership skills, then we want to hear from you!

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

The role:

This is a key role reporting to the Director of Quality, based in Europe, you will be the person accountable for EU activities within the region. You will be providing technical support, coaching and supervision to the quality assurance team and the business teams. In this hands-on role you will be responsible for the day to day running of the quality teams and QA systems. Your main focus will be ensuring the timely batch review and release and maintaining and developing the PQS to ensure continuing compliance with GMP’s.

  • Managing staff within the QA systems and quality operations teams
  • Leading site real time review of incidents, issues, and events in relation to MA, MIA, GMDP, and WDA(H) to determine the correct incident categorisation, investigation, and quality approval
  • Responsible the development of staff and the development of staff. This includes mentoring and on the job training of quality staff and other site staff in all relevant aspects of site pharmaceutical quality system
  • Leading the site quality improvement objectives identified and prioritised by site risk management activity, supporting site stakeholders to achieve goals
  • Responsible for inspection readiness activities for customer and competent authority regulatory audits
  • Acting as key quality lead in hosting competent authority and customer audits and to ensure closure of committed actions for competent authority inspections and customer audits are completed within agreed timescales
  • Ensuring deviations are fully investigated, and appropriate corrective and preventative actions have been raised
  • Ensuring that the root cause analysis process or risk/impact assessment process is followed for incidents and deviations, with appropriate quality oversight
  • Ensuring an effective process is in place for the training activities and improvement of training of all site personnel
  • Coordinate metrics of training to ensure responsible persons in each department are fulfilling their responsibilities
  • Coordinate site surveillance of regulatory updates to EU GMDP
  • Facilitate product batch release following EU GMP guidelines/regulations in all product release issues act as key solution enabling factor

About you:

  • University degree in Life Science, Chemistry, Biology or Pharmacy (Biotechnology or Pharmaceutical Sciences                   
  • Post graduate degree in Life Science, Chemistry, Biology or Pharmacy (Biotechnology or Pharmaceutical Sciences would be advantageous
  • Ability to mentor, coach and develop a team                  
  • Eligible to act as a deputy Qualified Person        
  • Trained/Approved IRCA Lead Auditor                
  • A progressive career in the pharmaceutical industry with experience gained within either production, Quality or QC                
  • Good knowledge of EU GMDP & GLP
  • Fluency in English and Dutch   

What we offer:

We offer a competitive salary and rewards package including holiday, health & wellbeing program, employee recognition awards, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

Apply now and become part of our team

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