Senior Manager R&D Quality

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 9 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 plans Promote 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 leadership Define metrics and measures for R&D Quality to drive assessment and continuous improvement Oversee GCP Quality investigations in collaboration with cross functional department owners Participate and represent R&D Quality in meetings and discussions as needed Participate in the metrics review as part of the Quality Management Risk approach to identify gaps, trends, and the need for process improvements Support the inspection readiness activities and participate in managing regulatory health authority inspections as needed Oversee Quality activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development Support routine and for cause audits of investigative sites and vendors and support internal audits Develop, 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 management Implement 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 requirements Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors 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 Other 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 scheme Company shares (generous welcome grant and performance-based annual equity plan!) In-house and external learning and development opportunities Fantastic 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 Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeiGene 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 ( ).

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.

#J-18808-Ljbffr