Clinical Quality Assurance Manager - Belgium
- To partner with Global Projects and Development, Global Medical Affairs and Drug Safety in driving quality into the clinical activities across the company's sites.
- 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 to the company's activities which are regulated by GCPs.
- This position will support operations related to international development of new drugs and/or new indications.
Role and main tasks:
- Lead the development of a risk mitigation program in support of broad range of routine situations for moderately complex clinical programs. Prospectively identify critical quality risk factors and potential impact. Apply corrective actions in moderately complex situations by cooperating and working with business partners and key stakeholders through the clinical governance model.
- 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 clinical program(s) that will include global clinical investigator audits, inspection readiness visits, database reviews, system audits and document reviews, etc.
- Routinely review and coordinate the output of trends from the risk mitigation program.
- Share with senior management and external peers the clinical quality risks of the clinical program at predetermined intervals.
- 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.
- Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses. Lead Rapid Response Teams to execute preparation, hosting and follow-up strategies.
- Act in an advisory role for key colleagues, business partners and stakeholders.
- Support the assessment of vendors of clinical and ancillary services.
- Coach and mentor junior colleagues, builds talent and teams, communicates openly, effectively and positively.
- Ensure that 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.
- 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.
- Bachelor degree required
- Demonstrated knowledge and understanding of applicable global regulations, quality principles and techniques and trends in the pharmaceutical area.
- Excellent working knowledge of GCP, applicable regulations, and best practices relative to the development of pharmaceutical products and/or commercial requirements. This is a must.
- Knowledge of industry trends and best practice.
- In-depth knowledge of worldwide regulations pertaining to GCPs for pharmaceutical products and the company's policies and procedures:
- 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, company's policies and procedures
- 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, is a plus.
- Excellent writing, verbal, listening skills. Good presentation skills. Should be able to communicate confidently with peers, clients (internal/external), and local management.
- Possess management and organisation skills in an environment of rapidly changing priorities. Demonstrates accountability. Recognizes and rewards individual and team achievements.
- Commitment to high standards of quality, integrity and reliability. Ability to set challenging goals, optimize resources, take initiative and achieve results.
- Team player capable of fostering spirit in an energizing way. Motivated, energetic and enthusiastic with ability to influence audiences, stakeholders, colleagues and business partners across the organization. Ability to operate in cross cultural team environment.
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.