Director, GCP Quality Assurance
Xcene Research
Management & Business Development
Job Summary
The Director, GCP Quality Assurance is responsible for establishing the vision and implementing the associated strategy for the clinical Quality Assurance function. This responsibility includes the development, execution and maintenance of risk-based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Xcene Research procedures and clinical trial protocols. The Director, GCP QA is responsible for overseeing the development, maintenance and continuous improvement of departmental processes and procedures that support the implementation and continuous improvement of GCP systems. Additionally, the Director GCP QA is responsible for deploying cross-functional GCP inspection readiness plans as needed. This position fosters and promotes a GCP compliant environment with internal and external stakeholders ensuring established Xcene Quality Systems are deployed. The Director, GCP QA is responsible for management of direct reports, including contracted consultants, and is expected to exhibit exemplary organizational and leadership values. This function is the internal GCP expert within Quality Assurance.
- Minimum Qualification : Degree
- Experience Level : Executive level
- Experience Length : 15 years
Job Description/Requirements
Responsibilities:
- Establish the vision and implement the associated strategy for the clinical Quality Assurance function within Xcene.
- Manage and/or participate in complex audits, including but not limited to, internal processes, external vendors, and clinical investigator sites; determine compliance status and identify compliance risks.
- Institute comprehensive GCP inspection readiness plans for regulatory authority inspections of Xcene.
- Conduct the GCP inspections. Direct the development of adequate and appropriate responses and resolutions to identified observations. Drive timely completion of the agreed corrective and preventive actions.
- Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting at all times with an appropriate sense of urgency.
- Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends, and driving improvements thus identified.
- Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.
- Attend clinical sub-team and ad hoc meetings internally and externally, at investigator meetings as needed, to present quality system expectations and GCP training.
- Ensure policies and/or procedures within clinical research, such as Clinical Development, Clinical Operations, and other departments, are adequate to achieve the goal of building quality within clinical research programs and activities, particularly focusing on a risk-based approach.
- Perform a detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs, and other essential documents prior to their Quality Assurance acceptance or approval.
- Oversee company-wide required annual GCP training.
- Continuously remain up to date with the latest industry changes regulatory requirements, and industry standards and provide consultancy on quality/ compliance/regulatory-related issues.
- Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives, particularly those related to the application of new and revised industry standards, guidelines, and regulations within all affiliated areas of GCP.
- Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
- Develop productive, dynamic, professional working relationships, especially with colleagues in other Quality Assurance functions, as well as those in the embedded compliance operations functions.
- Establish goals for the GCP Quality Assurance department and ensure those goals are achieved.
- Supervise, support, and train staff in the execution of their functions ensuring audits and inspections are executed successfully, performance goals are met, and development needs are identified and supported.
- Effectively manage staff wherever they may be located
- Participate in the development and management of the departmental budget.
- Perform other duties as assigned.
Requirements:
- Director should have a minimum of 15 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent, and with at least 10 years in quality or compliance.
- Extensive experience in GCP auditing and managing regulatory authority inspections is required.
- Bachelor’s or master’s degree in a scientific or life sciences discipline. A healthcare background is preferred.
- Ability to demonstrate a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop, and coach others, oversee, and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.
- Ability to work professionally with highly confidential information.
- Ability to manage assignments and effectively deliver all expected deliverables in an organized and timely manner and proactively communicate changes in pre-established goals and deadlines.
- Ability to lead and manage multiple responsibilities.
- Be willing to travel when necessary
Knowledge and Experience:
- In-depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures.
- Demonstrated ability to define and implement procedures which ensure compliance to GCP and regulatory standards.
- Extensive experience in and knowledge of internal and external GCP auditing and quality systems operations.
- Wide-ranging experience leading regulatory authority inspections of clinical research activities, particularly in the Africa, US and EU, but also in Rest of World regions.
- Proficient hands-on experience managing quality and compliance-related projects and programs.
- Proven ability in driving GCP process improvement initiatives.
- Balanced approach to issue management and risk mitigation planning.
- Consistently and confidently exercise independent, sound judgment in making decisions.
- Current and in-depth knowledge and application of international requirements of Good Clinical Practice (GCP), ICH GCP Guidelines, regulations, and compliance initiatives globally applicable to the conduct of clinical trials.
- Strong knowledge of health authority submission activities, specifically in relation to GCP, for regulatory filings in Africa, the USA, the EU, and the Rest of the World regions.
- Exemplary cross-functional partnering and collaboration skills.
- Demonstrated exceptional engagement and Interpersonal skills.
- Ability to translate technical knowledge into guidance that is appropriate for audiences with differing degrees of experience.
- Ability to manage multiple projects in a demanding fast-paced environment.
- Excellent oral and written communication skills for effectively interfacing with other departments within the company, vendors, investigator sites, health authorities, and others.
- Highly detail-oriented with critical document/ process/ procedure/ system review competencies.
- Outstanding leadership experience and mentoring skills to ensure team members have the coaching and mentoring necessary to be successful.
- Skilled in budgetary management.
- Superior computer literacy in MS Word, Excel, and PowerPoint.
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