97 applicants

Company

BeiGene · 1 day ago

Director, GCP Compliance, Americas

United States

Full-time

Remote

Director/Executive

$159K/yr - $219K/yr

10+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

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Responsibilities

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 external 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 appropriate.

Liaises with site oversight managers and global/regional study leads to provide input into quality oversight visit planning.

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GCP complianceQuality AssuranceStrategic PlanningICH GCP knowledgeRegulatory ComplianceMicrosoft WordMicrosoft ExcelMS ProjectMS PowerPointMicrosoft Outlook

Required

Minimum of 10 years progressive experience in the biotech/ pharmaceutical sector, with minimum of 6-8 years in GCP-related discipline/quality assurance role

Solid leadership and demonstrated experience with strategic planning, prioritizing and management of initiatives and projects

Exercises sound judgement and discretion in matters of significance

Has excellent working knowledge of ICH/GCP, local regulations, SOPs and Clinical Operations Work Instructions and strong aptitude to learn about evolving regulations

Ability to work independently and effectively handle multiple priorities in a fast-paced environment

Excellent interpersonal skills, strong organizational skills and ability to influence and lead both with and without authority in a matrix organization

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Strong written and verbal communication skills

Benefits

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Company

BeiGene

Glassdoor

3.1

BeiGene is a global oncology company.

Founded in 2010

Cambridge, Massachusetts, USA

10,001+ employees

https://www.beigene.com

H1B Sponsorship

BeiGene has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (28)

2022 (36)

2021 (34)

2020 (22)