BeiGene
Overview
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer. Responsibilities
Serve as the GTS Quality Business Partner and interface with the global Quality organization; develop effective relationships with key Quality leaders and stakeholders. Act as the principal interface between Quality and GTS to solicit, formulate, manage vendor proposals/contracts, engage cross-functional stakeholders, and execute technology projects. Develop collaborative relationships with Quality & GTS to leverage shared services, drive economies of scale, and realize value through process and technology harmonization aligned with the global GTS strategy. Review and assess demand requests, explore new ideas and enhancements, and evaluate legal/regulatory requirements relating to data integration and analytics. Lead and/or support projects and ongoing, business-driven change initiatives with value-driven business cases and well-defined implementation plans. Partner with key stakeholders to ensure robust investment governance and measure project outcomes. Work closely with manufacturing sites to develop business cases for programs and projects; define measurable outcomes, deploy, maintain, and support QA & QC solutions. Generate and maintain a strategic digital roadmap for Quality capability, with demand management, resource management, release planning, and incremental capability growth. Monitor external industry trends and supplier capabilities to drive continuous improvement. Develop strategies for new product introduction and new technology deployment. Support strategy, deployment, and quality operations at manufacturing plants in China and the United States. Understand the global Quality, risk, and regulatory environment to plan activities for compliance with existing and new regulations. Supervisory Responsibilities
Technical leadership or supervisory responsibilities over the GTS Quality team. Strong team player who engages with peers to define, sponsor, and execute continuous improvements. Solid leadership, technical writing, and communication/presentation skills. Strong experience in business analysis and process mapping. Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies. Education and Experience
Education Required:
Bachelor’s degree in Engineering, Computer Science or related technological field and minimum 10 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems, or Education Required:
Master’s Degree in Engineering, Computer Science or related technological field and minimum 7 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems. Other Qualifications
Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a manufacturing or operations environment. Strong experience with any two of the following platforms: Veeva, LIMS, CDS and/or other Quality platforms. Validation practices (GAMP). Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents. Experience in managing small to medium-sized projects and outside vendors. Travel
Periodic domestic and international travel, less than 20%. Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies, 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 Salary and Benefits
Salary Range: $203,900.00 - $273,900.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, education or training, and location. Packages may vary by location. The recruiter can share more about the specific salary range for a preferred location during the hiring process. The listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible for the annual bonus plan; Commercial roles are eligible for incentive compensation. All employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and participation in the Employee Stock Purchase Plan. The company offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Equal Opportunity
BeOne is proud to be an equal opportunity employer. BeOne 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 applicable law. All employment decisions are based on qualifications, merit, and business need. Applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passion for fighting cancer. Responsibilities
Serve as the GTS Quality Business Partner and interface with the global Quality organization; develop effective relationships with key Quality leaders and stakeholders. Act as the principal interface between Quality and GTS to solicit, formulate, manage vendor proposals/contracts, engage cross-functional stakeholders, and execute technology projects. Develop collaborative relationships with Quality & GTS to leverage shared services, drive economies of scale, and realize value through process and technology harmonization aligned with the global GTS strategy. Review and assess demand requests, explore new ideas and enhancements, and evaluate legal/regulatory requirements relating to data integration and analytics. Lead and/or support projects and ongoing, business-driven change initiatives with value-driven business cases and well-defined implementation plans. Partner with key stakeholders to ensure robust investment governance and measure project outcomes. Work closely with manufacturing sites to develop business cases for programs and projects; define measurable outcomes, deploy, maintain, and support QA & QC solutions. Generate and maintain a strategic digital roadmap for Quality capability, with demand management, resource management, release planning, and incremental capability growth. Monitor external industry trends and supplier capabilities to drive continuous improvement. Develop strategies for new product introduction and new technology deployment. Support strategy, deployment, and quality operations at manufacturing plants in China and the United States. Understand the global Quality, risk, and regulatory environment to plan activities for compliance with existing and new regulations. Supervisory Responsibilities
Technical leadership or supervisory responsibilities over the GTS Quality team. Strong team player who engages with peers to define, sponsor, and execute continuous improvements. Solid leadership, technical writing, and communication/presentation skills. Strong experience in business analysis and process mapping. Ability to quickly assimilate knowledge of new platforms, languages, tools, and technologies. Education and Experience
Education Required:
Bachelor’s degree in Engineering, Computer Science or related technological field and minimum 10 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems, or Education Required:
Master’s Degree in Engineering, Computer Science or related technological field and minimum 7 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems. Other Qualifications
Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a manufacturing or operations environment. Strong experience with any two of the following platforms: Veeva, LIMS, CDS and/or other Quality platforms. Validation practices (GAMP). Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents. Experience in managing small to medium-sized projects and outside vendors. Travel
Periodic domestic and international travel, less than 20%. Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies, 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 Salary and Benefits
Salary Range: $203,900.00 - $273,900.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, education or training, and location. Packages may vary by location. The recruiter can share more about the specific salary range for a preferred location during the hiring process. The listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible for the annual bonus plan; Commercial roles are eligible for incentive compensation. All employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and participation in the Employee Stock Purchase Plan. The company offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Equal Opportunity
BeOne is proud to be an equal opportunity employer. BeOne 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 applicable law. All employment decisions are based on qualifications, merit, and business need. Applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
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