BeiGene (NASDAQ : BGNE; HKEX : 06160; SSE : 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 candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 10,000 colleagues across five continents. For more information, please visit www.beigene.com.
The Director, GCP Compliance, Americas provides quality guidance, expertise and leadership to the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates effectively with stakeholders within the region Americas as well as with global stakeholders including the Global Clinical Operations Compliance Lead / Global Clinical Operations Excellence Head to ensure compliance-related needs of the business are met. Establishes measures to reduce compliance risks and enhance successful clinical trial conduct in the region.
Essential Functions of the job :Responsibilities - may include, but not be limited to :Provides team leadership, including guidance, oversight and GCP expertise.Fosters a collaborative working relationship with key stakeholders (e.g. regional study team members, global clinical operations compliance team members, ..), to enable timely identification of potential problems, to ensure proper root cause assessments and corrective and preventative actions are in place.Supports regional compliance team through guidance in drafting responses and corrective and preventative action plans to internal / external audits and externa inspections as required.Identifies potential compliance matters and drives development and implementation of methods for improvement and resolution.Identifies trends in quality events for the region and shares these with the global compliance team as required.Provides expertise and guidance on initiatives involving processes and systems intended for use in clinical trials to ensure compliance with ICH GCP and any local regulations.Leads the development of a GCP inspection readiness programme at a regional level in alignment with global inspection readiness activities.Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriateLiaises with site oversight managers and global / regional study leads to provide input into quality oversight visit planningGeneral Requirements :Minimum of 10 years progressive experience in the biotech / pharmaceutical sector, with minimum of 6-8 years in GCP-related discipline / quality assurance roleSolid leadership and demonstrated experience with strategic planning, prioritizing and management of initiatives and projectsExercises sound judgement and discretion in matters of significanceHas excellent working knowledge of ICH / GCP, local regulations, SOPs and Clinical Operations Work Instructions and strong aptitude to learn about evolving regulationsAbility to work independently and effectively handle multiple priorities in a fast-paced environmentExcellent interpersonal skills, strong organizational skills and ability to influence and lead both with and without authority in a matrix organizationComputer SkillsEfficient in Microsoft Word, Excel, MS Project, MS PowerPoint and OutlookOther Qualifications :Strong written and verbal communication skillsTravel :Up to 10-15%Supervisory Responsibilities :Supervisory Responsibilities :Oversees the work of direct / indirect reports to ensure on-time, on-target and within budget results.Conduct regular 1 : 1 meetings and any other staff meetings incl mid-year and year end performance appraisals for direct reports which includes providing constructive feedback. Engages in career development planning for direct reports.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.
