Head of Quality
Head of Quality
Perrigo
Herrenberg, Germany
Job purpose
To proactively lead the quality team and ensure the site meets all external regulatory, customer and internal stakeholder requirements with regard to quality management systems and high quality, compliant products, in the most effective and efficient manner. To support new product launches and market expansion across all on-site product categories.
Responsibilities
- To organise the quality team in such a way to provide the most effective and efficient means of meeting regulatory, customer and internal stakeholder requirements;
- To build effective, mutually beneficial working relationships with the Site Lead, Head of Operations, Senior Management and key Stakeholders internally on site, and Perrigo corporate to ensure highly effective teamwork and to deliver high quality, compliant products in line with scheduled business priorities. In addition to use knowledge, education and experience to offer value adding solutions;
- To host Competent Authority inspections, Notified body and customer audits as required and ensure robust and timely corrective actions are implemented in such a way as to maintain excellent compliance, effectiveness and efficiency and continuous improvement of quality standards;
- To proactively prevent problems and to expediently address them as they arise by assimilating all scientific, objective information, utilizing your extensive QA and QC knowledge, education and experience to deliver timely, compliant and SMART solutions that support ongoing compliance, effectiveness and efficiency;
- To set goals and objectives for the quality team to ensure focused drive, ongoing effectiveness, efficiency and compliance and to monitor and measure performance to these goals and associated KPI’s;
- To support the quality team to achieve and surpass objectives, identifying and supporting development opportunities including technical/scientific excellence. To fully engage in succession planning for long term business success;
- To review and approve key documents within the business and to publish, respond and improve key quality metrics. To host the executive management review meetings;
- To support Environmental Health & Safety and Continuous Improvement on site.
Your profile
- Qualified to a minimum of first degree or equivalent within a scientific discipline (for example chemistry, biology, pharmacy);
- Minimum 12 years experience within the pharmaceutical/healthcare regulated industry most of which should relate to quality (covering design, develop, manufacture, testing, packaging storage and distribution of products) with at least 2 years within a senior quality role;
- Demonstrable strong relationship with Competent Authorities/other regulatory authorities, professional working groups etc.;
- Direct experience of effective management of teams with a proven ability to lead and inspire people to achieve and exceed defined goals and to appropriately manage situations where this is not the case;
- Fully conversant with EU pharmaceutical legislation including recent updates. Proactively identifies updates, shares with the business and offers effective, efficient proposals where applicable. Can demonstrate good understanding of GMPs for Cosmetics and Biocide products;
- Qualified Person status is not essential but is an advantage. Prior knowledge of ISO22716 and EU 528/2012 would also be an advantage;
- Excellent report writing skills – powerful and succinct to identify the issue, risks and proposed solutions;
- Highly evolved communication skills both written and verbal with a proven ability to influence at all levels.
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