QA Team Lead

Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a QA Team Lead to be responsible for leading, supervising, managing and training the QA Quality System team and continuously improve the local Quality system and provide training & support for Quality relevant systems.

Job Responsibilities:

• Management and oversight of the document control process from creation to obsoleting including archiving.
• Assure compliance to EU and FDA GxP, the organisations QMS and QA GMP operations, any other applicable regulations/standards.
• Assure compliance to FDA and MHRA regulations and ensure retention of MIA(IMP) and MS Licenses.
• Lead "Level 1" meetings for own team.
• Implementation and Management of the Quality Management System.
• Management of GMP Document Management, including Document Control.
• Generation, Review and approval of relevant GMP documentation.
• Oversight, review and management of Risks, Quality Events including incidents, deviation, investigations, change controls and CAPA ensuring they meet timelines.
• Coordinate and complete Preparations for Regulatory inspections.
• Management of the Quality Systems Team and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development.
• Actively develop, mentor, train and instil a quality culture.
• Ensure that own work and teams work complies with GMP, Data Integrity & Good Documentation Practice and is undertaken in accordance with applicable quality documents e.g. SOP's, BMR's, Protocols, Guidance's, etc.
• Perform other QA related tasks as assigned by the QA Manager GMP.

Key Skills:

• Excellent verbal and written communication skills.
• Excellent interpersonal skills with the ability to appropriately challenge others behaviours.
• Pragmatic / common sense approach to quality incidents.

Requirements:

• Relevant Science based degree e.g. Chemistry, Biology, Pharmacy.
• Experience working in a GxP environment including a minimum 6 years' experience in Compliance and Quality Assurance.
• Working knowledge of the principles and guidelines for cGMP as out in UK "Orange Guide", EU "Eudralex Volume 4", U.S. "CFRs" and other relevant regulations/guidelines.
• Hands on experience with defining and implementing Quality Management Systems.
• Leadership and Management experience of successfully managing small teams is preferred.
• IT literate, experience managing and operating an electronic QMS.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.