Head of CTS Quality & Regulatory
Job Details
Full Job Description
Company Description
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.
Job Description
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
Qualifications
A degree in a relevant scientific discipline is preferred