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 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. 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% travel

All 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.