Director, GCP Compliance

October 3

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501 - 1000

Description

• Provides team leadership, including guidance, oversight and GCP expertise. • Fosters a collaborative working relationship with key stakeholders to enable timely identification of potential problems. • Supports regional compliance team through guidance in drafting responses and corrective and preventative action plans to internal/external audits. • 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. • 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. • Liaises with site oversight managers and global/regional study leads to provide input into quality oversight visit planning.

Requirements

• 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. • 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