Clinical Quality Manager (remote-based)

A fantastic vacancy has become available for a Clinical Quality Manager to work remotely for a drug discovery and development organisation focused mainly on Severe Asthma & COPD. If this is something you are interested in, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• To support facilitation and maintenance of the GCP Quality Management System (GCP QMS)
• To participate in quality assurance projects and continuous improvement activities for GCP
• To attend, contribute to, and conduct internal and supplier GCP audits
• To support the tracking and resolution of GCP corrective/preventative actions (CAPA) and associated commitments
• To assist in monitoring of legislation, guidelines and the national regulatory environment to maintain GCP intelligence and awareness of compliance and best practice within the company
• To work in collaboration with quality team members from other GXP regulated activities to support overall integration of the company QMS.
• Collaboration with the Head of Quality, CEO and Quality Management Consultant to support ongoing development, implementation and maintenance of the GCP quality system as an integral part of the corporate quality system.
• Act as a GCP and GCLP Quality point of contact for internal and external contacts.
• Collaborate closely with the Head of Clinical Operations regarding implementation of quality activities within the clinical function, including audits, deviations, CAPA follow-up and QC activities.
• Ongoing maintenance of the Quality controlled document system, including SOPs, procedural documents and any associated forms and templates.
• Working with Process Owners to provide guidance on the creation of SOPs and procedural documents.
• Assist with conducting quality and compliance reviews of new and updated procedures.
• Assist as required with conduct of quality control reviews of new and updated GCP documents and compilations.
• Provide support for the development of training materials for new and updated procedures.
• Support the review and update of all GCP procedures within the company-defined review periods.
• Maintain good awareness of current legislation, regulatory guidance and company policies to ensure these are reflected in GCP procedures.
• Identify opportunities for continuous improvement of processes for clinical trial related activities.
• Identify process efficiency/effectiveness issues and help in facilitating solutions for improvement.
• Provide support for GCP quality verification and oversight including support for development of corrective action plans for activities not meeting quality standards.
• Support Clinical Operations teams for implementation of Quality Plans for clinical trials.
• Support and maintain quality activities for oversight of vendors, suppliers and subcontractors to ensure they are functioning appropriately; conduct, attend and support audits as required.
• Support GCP QMS change control activities, and update of CAPA (corrective/preventative actions) tracking systems.
• Support GCP teams in the conduct of root cause analysis of quality issues.
• Quality representative at Global Quality Management Team meetings, project and programme meetings as applicable.

Requirements:

• At least 5 years' experience in quality assurance in the pharmaceutical / biotechnology industry.
• Ability to effectively interact with internal cross functional teams and third party vendors.
• Extensive working knowledge of worldwide GCP regulations.
• Experience of hosting and managing regulatory GCP inspections.
• Experience of conducting audits and quality reviews.
• Experience of providing GxP advice.
• Educated at a Bachelors or higher graduate degree in a science related field, or equivalent experience.
• Experience with developing SOPs and department processes.
• Experience with training staff.
• Excellent written and verbal communications skills with strong proficiency in English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.