General Description:The Senior Manager, GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will beprimarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices. Also responsible for the organization, planning, process and logistics of all health authority inspections.Essential Functions of the job:Manage and oversee the GCP Quality Assurance activities:
Conduct and/or oversee the quality assurance (QA) inspection readiness activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development
Support and manage the inspection readiness activities and participate in managing regulatory health authority inspections.
Develop/improve and manage quality systems and processes to include:
Creation/revision of appropriate SOPs
Implementation and maintaining key QA systems, such as; investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans.
Supporting the activities related to the vendor management process training, SOPs, etc.
Supporting/managing pre-inspection visits at both investigator sites and vendors.
Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc.
Defining metrics and measures for GCP Quality Assurance 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
Support and manage GCP Quality investigations
Coordinate and/or administer GCP training, as needed
Facilitate and manage inspection readiness meetings and represent Clinical Quality in meetings and discussions as needed
Develop a Managing Regulatory Inspections training program for the company and provide training on a periodic and as-needed basis
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.
Promote continuous improvement
Expert knowledge of GCPs particularly FDA and ICH requirements
Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Ensure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all issues for timely closure
Participate in vendor audits in accordance with BeiGene standard operation procedures, quality policies and/or plans
Create a central repository of all global/local regulatory inspection requirements and practices
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
Proven ability in setting strategy for and driving quality process improvement initiatives
Strong leadership experience and mentoring skills
Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations
Ensure all logistics are arranged for any Health Authority inspection (remote or on-site).
Other duties as assigned
Supervisory Responsibilities:This position may include managing staff: coaching and mentoring of junior staff 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.Computer Skills :
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:Education Required: Bachelor’s degree w/ 7+ years’ experience or Masters with 5+ years, preferably in science.Communication & Interpersonal Skills
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
ASQ certification is preferred
Significant Contacts
Quality Assurance
Clinical Operations
Pharmacovigilance
Clinical Business Operations
Biometrics
Medical Monitors
Regulatory Affairs
Interacts with all levels of BeiGene
Travel:May require up to 20% travelAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
