Global Quality Systems Manager

hace 5 días


Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completo

About Us

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Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals. The company produces and sells intermediates, active pharmaceutical ingredients, and finished dosage forms.

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We stand proudly at the centre of modern healthcare as a maker of essential and life-saving medicines. With our commitment to Quality, Reliability, and Sustainability at the heart of everything we do, our over 2200 employees work continuously to meet our customers' needs.

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We are committed to a sustainable future by actively participating in the fight against antimicrobial resistance.

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Job Description

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The QMS Manager will define/revise and implement a clear and robust document hierarchy for global documents. Put in place an integrated documentation structure that is simple, effective, secure, and easily accessible.

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Standardize and harmonize global quality procedures and policies within the global quality organization. Support training and implementation of these procedures.

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Main Responsibilities:

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  • Define and implement a clear document hierarchy for global procedures and policies.\
  • Design and (re-)draft global quality procedures that are aligned to the current regulatory expectations.\
  • Revise or revisit Quality manual and other GxP documents, standardize, harmonize, and/or simplify as required.\
  • Ensure that the procedures are current and suited to evolving GMP and regulatory requirements.\
  • Timely revision and updating of global documents.\
  • Support development & continuous improvement of Centrient Quality Systems.\
  • Support leadership teams in regulatory inspections and customer audits.\
  • Support effective training of global procedures across Centrient Sites.\
  • Lead and/or support GxP quality audits and monitor corporate annual audit plan.\
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Requirements:

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  • Bachelor or post-graduate degree in Science, Pharmacy, or related field of study.\
  • +8 - 10 years of industry experience.\
  • Advanced level of English language (written and spoken).\
  • In-depth knowledge of cGMP and regulatory requirements.\
  • Proven skills in technical writing.\
  • Prior experience in similar roles with good organization skills.\
  • International exposure and ability to manage cultural differences.\
  • Ability to obtain commitment on required actions.\
  • Resourceful in finding and keeping abreast of the latest developments in the cGMP and regulatory environment.\
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Estimated Salary Range: $120,000 - $150,000 per year based on location and experience.

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About Our Company Culture:

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We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat, giving you a lot of freedom and responsibility in an open, direct, and informal atmosphere.

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Please submit your application via the 'apply' button and upload your CV & cover letter in English. We also ask you to include information on your current remuneration. Only applications with CV and Cover Letter will be considered.



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