The Senior Manager / Associate Director, GCP / GVP / GLP Quality is responsible for ensuring and fostering a pro-active, phase appropriate approach to GCP / GVP Quality Assurance.
This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.
For that the incumbent coordinates and conducts a variety of routine and complex GxP audits on assigned projects / products and provides independent assessments of the compliance of activities and processes with relevant regulations / guidelines (examples include but are not limited to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), ICH guidelines, local regulations and BeiGene SOPs / Working Instructions).
This position identifies and assesses areas of risk; liaise with relevant compliance person in development to establish corrective and preventative actions as well as appropriate risk management plans.
Essential Functions of the job : Support quality assurance (QA) activities related to EU, FDA and ROW regulations across therapeutic areas and provide guidance for all phases of drug development Develop / improve and manage quality systems and processes to include : Conducting / managing routine / for cause audit of investigator site, vendors, internal audits, etc.
Supporting the activities related to the vendor management process training, SOPs, etc. Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits Developing and managing Integrated Quality Management Risk plans Conducting / managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc.
Defining quality metrics and measures to drive assessment and continuous improvement Management and review of trends and report significant investigation / deviation issues and system deficiencies to senior management, as appropriate Coordinate and / or administer GCP / GVP training, as needed Participate in the review of study related metrics (i.
e. protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements Manage inspection readiness activities and contribute to regulatory health authority inspections Expert knowledge of GCP / GVP / GLP particularly EU, and ICH requirements Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations Other duties as assigned Supervisory Responsibilities : This position may include managing staff : coaching and mentoring of junior staff at a later point in time with training / orientation / qualification and development plan for new Quality staff when required.
Therefore, it is required to have strong leadership experience and mentoring skills. It also includes management of contract auditors.
Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.
Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.
Contributes to building a positive team spirit; Shares expertise with others. Adaptability Able to adapt to changes in the work environment.
Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. NO AGENCIES