Location: Barcelona, Catalonia, Spain - Category: Quality
Global Data Integrity Quality Manager
Centrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms.
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. We work towards a sustainable future by actively participating in the fight against antimicrobial resistance.
Founded 150 years ago as the ‘Nederlandsche Gist- en Spiritusfabriek’, our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
Reporting to the Corporate QA Director of CSV & Data Integrity and providing services to the Centrient Global Enterprise. You'll ensure compliance with Data Integrity best practice for all formats of data, (paper or electronic) according to applicable regulations and Corporate Policy and Procedure. This is a role with global oversight of all Centrient manufacturing sites and GXP functional units.
The role is to ensure compliance with cGMP as meant by US FDA CFR’s, EU GMPs Annex’s. Ensure Data Integrity Controls & Oversight are embedded in site and functional unit processes, thinking and acting. Coach and train site based personnel. Define and own Global Data Integrity processes and procedures, identify & monitor Data Integrity risks and ensure compliance. Report on local site and business unit risk mitigation plans and compliance to Corporate QA and local site and business unit leadership. Is a key contact for auditors.
The main activities and responsibilities:
- Responsible for maintaining and Developing Data Integrity and eDI Quality Management System Framework.
- Put in place a global assessment and mitigation for data integrity:
- Develop the assessment methodology.
- Develop the risk based mitigation strategy.
- Lead & support local sites execution.
- Monitor and evaluate local site execution.
- Develop metrics reporting for site execution.
- This includes responsibility to:
- Develop/refreshment of Data Integrity-related SOPs, Guidelines, Standards, Templates and Training materials to the agreed timescales for Global Compliance.
- Conduct in-depth monitoring reviews, provide assurance that business controls align with regulatory requirements and implement effective regulatory risk control.
- Acts as Subject Matter Expert on GxP Data Integrity.
- Organize trainings on Data Integrity processes.
- Define and maintain the Data Integrity compliance audit agenda.
- Participates in local site projects projects.
- Owns related local quality improvement projects.
- University degree in technical, science, chemical engineering or computer sciences.
- Minimum of 5 years’ experience within Quality Assurance and/or Data Integrity. Record keeping and Pharmaceuticals.
- Fluent in English language (written and spoken).
- Strong Quality and continuous improvement mindset.
- SME in GxP record keeping and data flow mapping and risk assessment.
- cGMP Data Integrity Requirements
- API / FDF data and record types
- Good Knowledge of GxP Analysis, Gap Assessment and 21 CFR Part 11 of USFDA.
- Project Management skills.
- Critical Thinking.
- Strong communications skills. Communicates effectively with a diverse audience.
- Intercultural skills.
- Independent and reliable worker.
Terms and reward
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. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.
Please submit your application before September 30th 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.
For more detailed information about the role and about the Recruitment & Selection process you can contact us via HRSpain@centrient.com We invite you to visit our website www.centrient.com for information about our company.
Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.