Senior Manager R&D Quality page is loaded Senior Manager R&D Quality Apply locations Sydney Australia - Home Office time type Full time posted on Posted 5 Days Ago job requisition id R23672 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. Job Description: About BeiGene: BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of over 10,000 colleagues across five continents.
About the Position: The Senior Manager of R&D Quality 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.
Essential Functions of the Job: Manage and oversee R&D Quality activities which include, but are not limited to:
Oversight of key QA systems such as investigations, Significant Quality Events (SQEs)/deviations, CAPAs, audits, developing and managing integrated Quality Management Risk plansPromote continuous improvement by partnering with key stakeholders to identify trends in quality events and ensure risk-based solutions are implemented in a timely manner and escalated to senior leadershipDefine metrics and measures for R&D Quality to drive assessment and continuous improvementOversee GCP Quality investigations in collaboration with cross functional department ownersParticipate and represent R&D Quality in meetings and discussions as neededParticipate in the metrics review as part of the Quality Management Risk approach to identify gaps, trends, and the need for process improvementsSupport the inspection readiness activities and participate in managing regulatory health authority inspections as neededOversee Quality activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug developmentSupport routine and for cause audits of investigative sites and vendors and support internal auditsDevelop, review, and approve Quality - documents (e.g., SOPs).Identify and escalate potential serious GCP non-compliances within R&D Quality management and relevant cross functional managementImplement existing Quality Strategy and divisional and department-specific guidelines in all areas for which the job holder is responsible. Qualification Required: Additional Qualifications: Expert knowledge of GCPs particularly ICH requirementsAbility to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factorsSuperb 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 operationsOther duties as assigned Education Required: Bachelor's degree, preferably in Science
Supervisory Responsibilities: This position may require mentoring of junior staff. Therefore, it is required to have strong leadership experience and mentoring skills
What we offer to our valued employees: Market competitive compensation package including performance-based annual bonus schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer:
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.
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 ClarityBeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations. Due to BeiGene's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene's Job Applicant Privacy Policy ( https://www.beigene.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us. 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 www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
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At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
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