Senior Manager/ Manager, Gcp Inspection Management

About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit

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Job Description:

- General Description:_

The Senior Manager/ 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

Qualification Required:
Education Required: Bachelor’s degree, preferably in Science

Computer Skills:

- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:
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
- Me