Head of CTS Quality & Regulatory

At BioOutsource we are building a world class team and have an interest in talented people. In order to sustain our position as a leading provider of contract testing services, we rely on our employees to deliver. As a result we continually strive to offer our employees an unparalleled level of opportunity and provide an environment that is driven by innovation and high performance.
 

While our company continues to expand, so does the opportunities available to our employees. If you would relish the opportunity to work in our vibrant, fast-paced and rewarding environment we would like to hear from you.

We fully understand the importance of our service to support our client’s critical testing requirements and as a result continually strive to provide a world class service.

Are you an outstanding Leader with the ability to thrive in a fast-paced environment?

Sartorius Stedim BioOutsource Ltd is looking to recruit an experienced individual to lead its Quality Team. This HOD role will report to the Head of Site, Glasgow and will be responsible for driving the performance of their team.

The Head of CTS Quality & Regulatory is responsible for the strategic direction of the Cell & Testing Services (CTS) Quality groups in Glasgow, Cambridge and Laupheim. The incumbent is responsible for Regulatory compliance of all CTS sites to the appropriate FDA, EU and local requirements.

Key Responsibilities & Accountability
Maintaining our regulatory licenses (e.g. MA(IMP))
Ensuring that GMP, GLP and GCP compliance is maintained throughout our GxP testing facilities and IMP licenced cell bank manufacturing facility.
Develop and implement a shared CTS Quality framework across all CTS sites
Design, effective implementation and monitoring of the QMS systems to meet the appropriate compliance, user, client, and business requirements.
Build a high performance Quality team
Responsibility for Head of QC duties as specified in Eudralex, Volume 4
Promote and maintain a Quality culture throughout the organisation.
Develop a client Regulatory support service

You will:

• Lead, develop, and recruit high performing Quality teams with appropriate regulatory knowledge to support current needs and future growth
• Overall management of the CTS Quality groups
• Maintenance and continuous improvement of the CTS shared Quality system
• Provide expert guidance and leadership on items relating to cGMP compliance, including compliance to Corporate Standards, Internal and External audits, processes, validation, process media simulations and process interventions and deviations.
• Host Regulatory Inspections and liaise with regulatory bodies (e.g. MHRA, FDA etc) as required
• Mange client audits
• Provide reports to the Heads of Sites on the climate of Quality within the CTS organisation
• Maintain the CTS Quality Budget
• Mentor, train and assess in Quality & Regulatory issues as required
• Provide advice / guidance on any compliance issues (e.g. complaints, OOS, deviations, CAPA, etc)
• Perform / assign duties as Deputy Archivist (as appropriate)

You’ll have:

• A degree in a relevant scientific discipline is preferred
• Experience in a licensed drug, or biologic facility regulated by FDA, EMEA in a senior quality role is essential
• Proven practical application of the Regulations essential, particularly:
o Directive 2001/83/EC, Directive(s) 2003/94/EC and 2011/62/EU
o Directive 2001/20/EC
o 2003/94/EC; Eudralex Volume 4
o QP training desireable
o UK Good Laboratory Practice Regulations, 1999 [Statutory Instrument 3106, as amended),
o Good Clinical Practice for testing laboratories
• Subject matter Expert in at least 1 areas of validation (assay, equipment, CSV)
• A Collaborative and Innovative style
• Proven Regulatory Compliance success preferably within a GMP or GLP environment
• Ability to challenge and simplify complex systems
• Implementation of automated systems experience essential
• Demonstrated leadership and motivational skills to create high performance teams
• Thorough understanding and experience applying EU and US GMP or GLP regulations
• Extremely organised approach is required coupled with the ability to influence without authority
• Excellent written and verbal communication skills coupled with the ability to prioritise multiple tasks and have the confidence to challenge existing systems & processes.
• Competent Word, Excel and PowerPoint skills
• Working knowledge of current pharmaceutical production technologies, QC procedures, and regulatory requirements.

You’ll get:

• A competitive salary
• A generous benefits package
• Full company overview and on-the-job training
• Significant opportunity for personal growth and development within a rapidly expanding, successful CRO.

Closing date: 5th December

A degree in a relevant scientific discipline is preferred