Director, Quality

Director, Quality

Catalent

Dartford, United Kingdom

As a member of the senior management team ensure an effective Pharmaceutical Quality Management system is in place. The Quality Director will provide leadership and daily management of the site Quality Assurance, Validation and Quality Control Departments. Quality Director will also be responsible to provide support to both the Dartford site business unit (BU) operations, as well as to the corporate Quality function.

The Role

• To ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the “Standards of Business Conduct”;
• To determine, establish and maintain comprehensive systems that establish document and monitor GMP Quality and ISO standards and that meet Catalent, Regulatory and Customer requirements;
• To ensure that the Dartford site complies with all Applicable Laws relative to Good Manufacturing Practice and ensure that all regulatory licenses are maintained and renew in line with different countries requirements as appropriate for the business;
• Manage the team against the site and Quality strategy objectives;
• To develop a Quality culture on site, such that the Quality team provides leadership and coaching to ensure GMP best practices are embedded throughout the site;
• To continually review the operation of the Quality function on site, and deliver a programme of continual improvement;
• To manage the Quality budget, ensuring well defined resource modelling;
• To act as a primary contact for senior Quality professionals within our customer organizations to ensure compliance and customer service standards are met;
• Other duties as assigned.

The Candidate

• Degree in Biology, Chemistry, Pharmacy or an equivalent qualification;
• To be eligible to act as a Qualified Person is preferable but not essential;
• Must have 10+ years’ experience of successfully leading a customer focused quality function including QA, QC and batch release within an API manufacturing environment or pharmaceutical manufacturing environment;
• Has participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, FDA, etc.;
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

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