Senior Manager Quality, Australia New Zealand

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:

General Description:

Ensure compliant and uninterrupted supply of BeiGene commercial products or the import products from collaboration partners in accordance with BeiGene’s quality management system and Australia/New Zealand countries’ regulatory authority expectations. Provide quality oversight of third-party vendors in Australia/New Zealand, clinical GMP quality activity and the management of temperature excursions, product complaints and deviations.

Essential Functions of the job:

•            Ensure local activities (AU/NZ) comply GDP (Good Distribution Practice) or relevant cGxP and BeiGene’s Quality Management System.

•               In country disposition / release activities for Australia/NZ and provide support as back up to other APAC countries as required.

•               Develop, update, and maintain local quality procedures and provide input into APAC process and procedures as required.

•               Complaint, deviation, clinical and commercial temperature excursion handling according the BeiGene QMS and as per regulatory requirements

•            Support the management of commercial/clinical product recalls, counterfeits, and product tampering according to the BeiGene QMS and the regulatory requirements.

•               Quality oversight of 3rd party providers within the commercial and clinical supply chain– including qualification, audits, quality agreements, monitoring activity, participate in KPI and business reviews and identify compliance trends that require improvement.

•               Participate / respond to audits and self-assessments for responsible countries including conduct as required self-assessments for other APAC regions.

•               Management of temperature sensitive products including quality support for lane qualifications, shipper qualification, temperature excursion assessments, transport validation

•               Complete the relevant quality activity and/or assessment required for change control particularly with new product introductions /lifecycle changes/distribution readiness.

•               GxP training content delivery for Australia and other APAC countries as required.

•               Act as delegate/back up to the Country Lead as required for critical systems.

•               Contribute and participate in the regional/global management review as subject matter expert for systems within remit.

•            Subject Matter expert and network representative for APAC region and provide system support to the region as required including deviations.

•            Provide onsite inspection support in country as required by the GMP compliance team.

•            Provide quality oversight for commercial programs – e.g., patient support programs

Core Competencies, Knowledge, and Skill Requirements

• Life sciences or equivalent tertiary degree or direct relevant experience to complete required responsibilities.
• Minimum of 10 years’ experience in pharmaceutical/biological pharmaceutical company
• Minimum of 5 years’ experience in quality management of imported commercial/clinical medicines.
• Experience in complaint handling and temperature excursion management
• Experience in oversight the drug wholesaler and distributors
• Knowledge and understanding of the current PIC/s Guide to GMP for Medicinal Products, US and EU Good Manufacturing Practices (GMP), and International Conference on Harmonization (ICH) guidelines.
• Experience with regulatory compliance inspections
• Experience with cold chain distribution and working with vendors throughout the supply chain.

Communication & Interpersonal Skills

• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
• Excellent time management and prioritization skills
• Proven success working on collaborative projects with supply chain, regulatory, commercial operations.
• Good written and verbal communication skills, interpersonal skills, and technical writing skills.
• Ability to manage stakeholders and escalate issues as appropriately.
• Successful at working from home across multiple time zones on an ongoing basis

Significant Contacts

• Interacts with all levels of BeiGene employees; CMOs, 3rd party logistics, wholesalers, customers.