Quality Specialist

Hobson Prior are recruiting for a Quality Specialist join a multinational healthcare company at their offices in Hertfordshire. This position will be responsible for implementing the controlled document strategy for PDQ and the supported business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.

Job Responsibilities:

• Supports establishment of GxP Global Procedural Documents throughout all of the company's development related organizational enterprises (gRED, pRED, PD, GPS and Affiliates) to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations.
• Build and up keep strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions.
• Working with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.
• Responsible to ensure that business partner expectations for Procedural Document strategy, materials and deployment are met.
• In collaboration with business partners ensure that Global Procedural Documents in the GxP process landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations.
• Is knowledgeable of all services and activities provided by PDQS, Standards, Systems and Processes Governance in order to provide business stakeholders with a comprehensive overview and effectively communicates this to stakeholders.
• Collaborates with a network of subject matter experts (SMEs) across the functional areas, supporting the Global Procedural Documents development.
• Contributes to the PDQS Standards, Systems & Processes Governance Team to set strategies and achieve the long-term goals and objectives of PDQS and PDQ as a whole.
• Supports internal process improvement projects.

Key Skills:

• Ability to build and maintain good relationships within PDQS and with key business partners externally.
• Strong interpersonal and stakeholder management skills, including a customer focused approach.
• Ability to identify problems and find resolutions in a complex environment or potential conflict.
• You are able to successfully work cross-functionally and in global teams.
• Analytical, organizational and planning skills.

Requirements:

• Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience.
• A minimum of 3-5 years in the pharmaceutical industry, preferably in pharmaceutical development and working in a GxP regulated area.
• In-depth knowledge of pharmaceutical development processes, including Quality Management Systems, and relevant GxP regulations.
• Experience in preparation, development and administration of GxP standards and processes.
• Demonstrated knowledge of GCP and/or GVP regulatory requirements.
• Broad understanding of global expectations of Regulatory Authorities in the area of pharmaceutical development.
• Experience developing multiple Procedural Documents simultaneously to high quality.

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.