Current Opportunity

Because people depend on us BTG, an international specialist healthcare company developing and commercialising products targeting critical care, cancer and other disorders, has an exciting opportunity:

Quality Lead
Biocompatibles UK Ltd, a BTG International group company Farnham
________________________________________________________________________________________ Broad Function To lead the effective management of core quality processes and support activities for Pharmaceutical Varisolve combination product and Medical Device Embolic Bead range of products in the Quality Assurance Department ensuring all goods manufactured and services provided by the Company meet cGMP and quality requirements of the Company, customers and regulatory authorities. Principle Responsibilities

Provide the leadership for the core quality system processes in parallel with other stream leads to ensure
effective management of the Farnham Quality System. Ensure that departmental objectives are implemented in line with the overall Quality /Corporate goals. The three key quality processes to be led by each of three stream leads include customer complaints (close interaction with pharmacovigilance / vigilance system / teams), change control and quality event / CAPA processes.

Assist in ensuring departmental understanding and compliance with the requirements of cGMP as applied to
Farnham range of products. As required, provide cGMP training and support to departments.

Ensure compliance to the BTG global Quality Management System, ensuring compliance to all relevant
Quality Standards and Regulatory requirements. Identify improvements / updates based on legislation changes.

Ensure effective coordination and QA leadership (as per stream lead) for the Farnham customer complaint
and /or change control and / or quality event / CAPA Teams, including initiating action plans, and as appropriate investigations root cause analysis, risk assessments and CAPA plans / qualifications; focus on Continuous Improvement opportunities.

Review and assist in process capability studies and statistical techniques as necessary, to support
continuous improvement. Initiate updates/tracking on status of core quality system processes

Assist in the management and execution of a compliant internal and external audit system. Ensure timely
completion of audits

Identify corrective and preventive actions, determine assignable root cause, complete failure investigations
and follow up to corrective and preventive actions, ensuring adequate and timely closure, as appropriate.

Conduct review of Change Control Requests, ensuring compliance with cGMP and quality standard
requirements. actions. Assist in the development of change control action plans. Follow up on recommended

BTG is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values: Openness Accountability Teamwork Integrity Delivery Continuous Learning

Current Opportunity
Because people depend on us

Maintenance of Quality System Dashboards, scorecards / Key Performance Indicators for the quality system
processes. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training as appropriate.

Prepare and present quality reports, data and Key Performance Indicators to management for review at
quality review meetings.

Participate in the development and maintenance of the Company's Quality System to meet the requirements
of the relevant regulatory authorities, Notified Bodies (if applicable) and ISO standards (as applicable) and all other applicable quality and regulatory standards.

Support other departmental activities as requested by department management or designate. Ensure that all interactions and engagements are carried out with the highest ethical and professional
standards and that all work is accomplished with quality and in accordance with BTG values.

Carry out other reasonable tasks as required by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements. Education and Experience

Degree in science discipline (chemistry, biology or medical technology preferred). Recognised Quality qualification, e.g. CQI Diploma in Quality (or demonstration of satisfactory experience
within QA department)

Significant experience in a drug manufacturing, medical device or biologics industry in Quality Assurance,
Quality Control or Quality Engineering position.

Demonstrated knowledge of document control systems. Experience with internal and external audit processes Demonstrated knowledge of cGMPs, Notified Body, MHRA, FDA regulations and SOPs.
Skills and Attributes

Demonstrated advanced computer skills Microsoft Office preferred. Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations
appropriate to the level of the audience.

Demonstrated success working in a team environment. Dynamic Quality professional and diligent in all matters of compliance.
Please send CV including cover letter to: hr@btgplc.com

BTG is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values: Openness Accountability Teamwork Integrity Delivery Continuous Learning