CLINICAL QUALITY MANAGER
Job Description
Industry: Pharmaceutical Manufacturing
Seniority for this role: Entry level
Zentiva has R&D centre based in Prague.. Our R&D team applies cutting-edge methodologies to develop and actively manage the lifecycle of active pharmaceutical ingredients, drive innovation in medicinal product formulation and bring bioequivalent and value-added medicines to European regulators for review and approval. The internal capability is augmented by a network of academic partnerships including the flagship ‘The Parc’ program and the ‘Open Innovation Program’. The Zentiva R&D centre in Prague gives the opportunity to participate in top scientific work to help deliver modern, accessible and affordable medicines to patients in Europe and beyond. Dozens of active research projects are done both under one roof, utilizing broad variety of modern equipment and expertise, and through partnerships with external subjects where expert synergies are built. Situated in the very heart of the company, the interfaces between R&D and the rest of the company are usually within hand’s reach, which is an excellent way to gain knowledge in associated disciplines such as regulatory affairs, intellectual properties, production, quality assurance, medical, and many others. Innovative culture in the R&D team is based on shared values such as respect, courage, teamwork and enthusiasm. Apply and learn more! CLINICAL QUALITY MANAGER POSITION PURPOSE Clinical Quality Manager plays a pivotal role in ensuring the quality, safety, data integrity and compliance of clinical trials. Oversees the quality processes in clinical trials (pharmacokinetics ,phase II/III, NIS) for in-house developed products, is responsible for preparation of the internal CDD guidelines SOPs, documents and templates, reviews external SOPs and performs GAP analyses, eTMF quality controls and in-licensed dossier audits. WHAT THE JOB IS ABOUT / KEY RESPONSIBILITIES AND ACTIVITIES DEVELOPING GCP-RELATED QUALITY SYSTEM IN CDD Creating internal departmental guidelines (GUIs) and standard operating procedures (SOPs) that align with all applicable regulatory requirements and corporate SOPs and guidelines. Ensuring compliance with Good Clinical Practice (GCP), regulatory requirements and local legislation in clinical trials and studies sponsored by Zentiva k.s. and conducted by Clinical Development Department Updating periodically the internal GUIs and SOPs taking into consideration new/updated regulatory requirements and corporate processes Providing overall support during internal audits and inspections at Zentiva, k.s. and clinical sites Ensuring appropriate GCP training and tracking overall compliance records to Clinical Development Department Developing study templates, logs and tools OVERSEEING CLINICAL TRIALS Ensuring that clinical trials are conducted in accordance with study protocols and regulatory requirements, including but not limited to checks of internal compliance with GUIs, SOPs, study plans, study contracts, essential study documents and regulatory requirements. Analyses of non-compliances identified CAPA management ( in cooperation with CDM) Immediate escalation of any critical outcomes of performed compliance checks to CDD/ HMA Providing overall support of the internal Quality Management System and Clinical Development Managers in Quality Assurance as needed Performing for-cause visits of clinical sites Assistance during site audits and regulatory inspections including preparation and follow up Vendor audits planning and execution Cooperation with CDD/CDM in vendor evaluation process focusing on analysis vendor’ s SOPs and performing gap analyses MAINTAINING SIGNIFICANT QUALITY KNOWLEDGE Regular communication, information and training the Clinical Development team about news in regulatory requirements and updated GUIs and SOPs Ensuring comprehensive and timely understanding of regulatory requirements, with a focus on adherence to the ICH E6 Guideline for Good Clinical Practice. Is assigned to or participates in other QA related tasks as needed Collaborating with Global QA and implementing corporate QM requirements in CDD Contributes to general departmental administration and continuous improvement of departmental procedures What Will You Need / Qualifications & Required Skills University Degree in life sciences Clinical trials quality know-how Problem solving Certification: relevant certification for GCP Managerial skills – cooperation within organization, with externals partners: Strong transversal cooperation skills to effectively introduce and/or enforce adequate quality standards Regulatory intelligence Respect, Teamwork, Professionalism, Enthusiasm, Courage Ability to work in cross-cultural teams, ability to work independently and to make educated decisions Strong communication and presentation skills. Fluent English Why Will You Like Working With Us An opportunity to work for a successful international pharmaceutical company An opportunity to learn newest approaches in managing creative and highly adaptive business organizations Pleasant and dynamic working environment Continuous personal development An attractive compensation & benefits package Motivating wage evaluation including an interesting bonus and benefits system Above standard social and benefit program Location: Prague Diversity is a fact. Inclusion is an act @Zentiva At Zentiva, we are a team of 5000 unique talents bonded together by our mission to deliver high quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. To learn more about our D&I commitment, click here. Join our winning team! Be a part of our winning culture! Be Zentiva! Show more Show less
