BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 developmentSupport 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 SOPsImplementation 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 improvementManagement and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriateSupport and manage GCP Quality investigationsCoordinate and/or administer GCP training, as neededFacilitate and manage inspection readiness meetings and represent Clinical Quality in meetings and discussions as neededDevelop a Managing Regulatory Inspections training program for the company and provide training on a periodic and as-needed basisParticipate 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 improvementExpert knowledge of GCPs particularly FDA and ICH requirementsAbility to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factorsEnsure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all issues for timely closureParticipate in vendor audits in accordance with BeiGene standard operation procedures, quality policies and/or plansCreate a central repository of all global/local regulatory inspection requirements and practicesSuperb 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 complianceProven ability in setting strategy for and driving quality process improvement initiativesStrong leadership experience and mentoring skillsStrong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operationsEnsure 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 skillsAbility to effectively collaborate in a dynamic environmentASQ certification is preferred

Significant Contacts

Quality AssuranceClinical OperationsPharmacovigilanceClinical Business OperationsBiometricsMedical MonitorsRegulatory AffairsInteracts with all levels of BeiGene

Travel: 

May require up to 20% travel

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $127,900.00 - $172,900.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.