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Clinical Quality Assurance Manager - Belgium, United States, Germany
Posted on : 09 December 2016
We are searching for a passionate colleague who can make an impact for patients in the Clinical Quality Assurance (CQA) Manager role. A CQA Manager partners with R&D, Global Medical Affairs, Global Clinical Safety and Pharmacovigilance and GMP Quality Operations in driving quality into the clinical activities across the sites to ultimately create patient value.
Nature and Scope:
- To design and implement a robust clinical quality risk management program that profiles and mitigates risks associated with patient safety, data integrity and regulatory compliance.
- To provide direct compliance and investigative support our activities which are regulated by Good Clinical Practices (GCPs).
- This position will support operations related to international development of new drugs and/or new indications.
- To lead the development of a risk mitigation program in support of broad range of routine situations for moderately complex clinical programs.
- To prospectively identify critical quality risk factors and potential impact.
- To apply corrective actions in moderately complex situations by cooperating and working with business partners and key stakeholders through the clinical governance model.
- To independently plan, coordinate and execute Clinical Quality Assurance (CQA) activities identified in risk mitigation programs to validate the systems and processes established to ensure subject safety and protection and to ensure clinical trials are performed and data are generated in compliance with international and national GCPs.
- Oversee risk mitigation activities for the clinical program that will include global clinical investigator audits, inspection readiness visits, database reviews, system audits and document reviews, etc.
- To routinely review and coordinate the output of trends from the risk mitigation program.
- To share with senior management and external peers the clinical quality risks of the clinical program at predetermined intervals.
- To ensure resolution of auditing findings through close collaboration with business partners, stakeholders and vendors.
- Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principals to collaborate effectively and influence approaches to quality and ensure expected work products and output are aligned with regulatory guidelines, ICH-GCP, applicable regulatory requirements and global quality standards.
- To assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses.
- To support the assessment of vendors of clinical and ancillary services for use by Development and GMA.
- Coaches and mentors junior colleagues, builds talent and teams, communicates openly
- To motivate and manage small teams to execute assigned tasks within a project to deliver results. Establish timelines, optimize schedules, and organizes team responsibilities to attain top performance requirements and global quality standards.
- Other duties as assigned
- Bachelor’s degree required
- Demonstrated knowledge and understanding of applicable global regulations, quality principles and techniques and trends in the biopharmaceutical area related to small/large molecule, device, combination products, mobile medical applications.
- Excellent working knowledge of Good Clinical Practice, applicable regulations, and best practices relative to the development of pharmaceutical products and/or commercial requirements.
- 3-5 years auditing experience (e.g. investigator site, vendor, system, database, device, IT)
- Ability to apply compliance and risk based principles in moderate to complex situations. and propose corrective actions in a broad range of routine situations.
- Ability to understand cross functional business partners, cultural drivers.
- Ability to work under minimal supervision, set challenging objectives, able to apply compliance principles in a variety of moderately complex situations.
- Capable of leading and motivating interdepartmental teams to achieve objectives of complex scope.
- Mobilize relevant colleagues and business partners when facing obstacles.
- Ability to gather consensus and influence colleagues, business partners, and key stakeholders across the organization.
- Inspires confidence, takes calculated risks, and sets challenging objectives for self and team.
- Knowledge and experience in auditing electronic systems and 21 CFR Part 11 computer system validation.
- Excellent writing, verbal, listening skills. Presentation skills necessary.
- Communicate confidently with peers, clients (internal/external), and local management.
- Ensures free flow of information to appropriate stakeholders.
- Possess management and organisation skills in an environment of rapidly changing priorities.
- Demonstrates accountability and actions taken.
- Commitment to high standards of quality, integrity and reliability.
- Ability to set challenging goals, optimize resources, take initiative and achieve results.
- Ability to travel nationally and internationally as business necessitates.
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