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General Description:

The Director Global Clinical Supply Compliance builds, collaborates and manages key relations to better support and understand the compliance-related needs of the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and expertise to Clinical Supply GCO stakeholders regarding GMP and GDP processes. In addition, develops partnerships with key enterprise business partners and stakeholders to advance GMP and GDP and GDP compliance solutions, embed preventive compliance and enable transparency, escalation, and resolution of GMP and GDP compliance matters.

This role reports to the Senior Director, Global Clinical Operations Compliance Lead.

Essential Functions of the Job:

+ Identifies and anticipates potential issues impacting the ability to meet business goals; develops and implements methods of improvement and resolution.

+ Independently leads and/or participates in global and cross-functional initiatives, working groups and project teams as a decision maker, subject matter expert or reviewer of initiatives and solutions to ensure compliance with GMP and GDP, applicable laws and regulations and consistency within BeiGene Quality Management System.

+ Understands end-to-end manufacture and labeling of clinical supplies and interfaces cross functionally. Understands Annex 13 and PSF.

+ Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective and preventive actions for quality issues, site non-compliance, audit and inspection findings are in place, and that lessons learnt are disseminated and actioned upon within the broader GCO organization. Identifies and escalates significant GMP and GDP compliance issues within GCO and to relevant leadership, including assessment of serious breaches.

+ Contributes to the design of study documents, as required, to ensure quality by design and preventative compliance.

+ Contributes to the design and implementation of risk identification and management strategy for clinical studies and other regulated drug development activities. Works collaboratively with internal and external business partners and key stakeholders to provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical study conduct and other regulated drug development activities to ensure compliance with GMP and GDP, applicable laws and regulations and BeiGene policies and procedures.

+ Maintains the highest level of expertise in global GMP and GDP guidances and regulations, industry best practices, and internal policies and procedures impacting drug development to promote quality and compliance within GCO. Embeds quality principles throughout the organization.

+ Provides input and support to CRO Joint Committee Forums through consultative guidance on the development of the key defining principles and documents.

+ Designs and conducts quality issue trending, analysis and review activities to proactively identify broader issues and/or patterns within GCO organization; leads the design and implementation of corrective and/or preventive actions, as applicable; escalates the identified issues with broader organizational impact within GCO and to relevant leadership.

+ Ensures provision of actionable data and insights regarding the state of quality and compliance to GCO leadership and other stakeholders as requested.

+ Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution in a pragmatic and effective manner. Supports QMS activities including self-reporting of deviations and quality issues, root cause analysis and CAPA plan development and evaluation.

+ Proactively researches, evaluates and makes recommendations associated with organizational impact of evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices as it relates to drug development quality and compliance.

+ Contributes to inspection preparation and management for local country and global Health Authority inspections.

+ Provides leadership (direction, oversight, guidance and subject matter expertise) to project teams as assigned.

+ Oversees the work of indirect/direct reports, as assigned, to ensure on-time, on-target and within-budget results. Provide ongoing mentoring, coaching, guidance and feedback to ensure indirect/direct reports are successful in their work, as well as have the necessary and timely access to information and other resources. Supports the professional development of direct/indirect reports, as applicable.

+ Conducts regular one-one-one and any other staff meetings to ensure timely communication with indirect/direct reports. Provides feedback on formal performance reviews and career development planning for all indirect reports.

+ Manages budget for assigned projects and/or activities. Maintains operational and budgetary awareness of overall GCO Compliance project portfolio, as applicable.

Supervisory Responsibilities:

+ May or may not manage direct/indirect reports as needed

Computer Skills:

+ Proficiency with computer systems utilized for everyday work: i.e. Word, Excel, PowerPoint, Visio, Outlook etc.

Qualifications:

+ Bachelor’s Degree with minimum of 10 years of experience in pharmaceutical or biotechnology drug development, preferably in a relevant field such as Quality Assurance, Supply Chain (commercial and/or clinical), Manufacturing, Regulatory Compliance, Clinical Development or a directly related area.

+ Minimum of 3+ years in GCP-related discipline/quality assurance role.

+ Has impeccable ethics. Exercises sound judgement and discretion in matters of significance.

+ Demonstrated experience with planning, prioritizing, and management of high-level initiatives and projects. Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity. Knowledgeable in stakeholder management and influencing change.

+ Proven interpersonal skills, customer focused approach and effective teamwork and collaboration skills.

+ Must demonstrate knowledge of and strong aptitude to learn about the evolving the legal and regulatory environment, GMP and GDP, applicable laws, regulations and industry standards as it relates to a global pharmaceutical organization.

+ Desirable Clinical supply chain background

+ Familiar with Annex 13 EudraLex and Product Specification File.

+ Familiar with the GMP and GDP product release process in major countries/jurisdictions .

+ Must demonstrate knowledge of the end-to-end manufacturing, labeling, quality control, and release process for clinical supplies and cross-functional interfaces within this process.

+ Must understand corporate (local and global) and organization (local and global) policies, procedures and guidelines.

+ Excellent organizational and planning skills; able to prioritize, identify conflicts and meet deadlines without direction.

+ Strong verbal and written communication skills. Highly adept at synthesizing and summarizing unusually complex and/or voluminous content in clear, concise, and actionable communications. Leverages these skills to work effectively and credibly with leaders across GCO and development.

+ Proven ability to lead the analysis and simplification of complex systems or processes into pragmatic solutions. Strong ability to analyze and simplify complex systems. Highly effective in analytical and strategic assessment of GMP and GDP compliance risks; able to articulate potential business impact.

+ Demonstrated ability to influence and lead both with and without authority in a matrix organization, leading innovation and change.

**Travel:** May be required (10-20%)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.