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Senior Manager R&D Quality Job in Australia Recruiting by BeiGene

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Senior Manager R&D Quality

🔖 Full Time

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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:

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