at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global QA function is looking for a Sr Dir, Global Preclinical & Clinical Quality Assurance (QA). This role will lead and manage the global Preclinical & Clinical QA organization and provides strategic Quality leadership across the company's pre-clinical, clinical development and pharmacovigilance activities, to ensure appropriate level of compliance with recognized regulations and guidelines. This individual designs, implements, and maintains QA and compliance programs in the area of GLP, GCP and GVP. The Senior Director is a member of the Quality Leadership Team and promotes Quality, GxP awareness and continuous improvement.
Essential Functions of the Job (Key responsibilities)
Lead, motivate and develop on-going competencies of a team of global Quality professionals.
Lead QA contact and partner for Preclinical, Clinical and Pharmacovigilance Management including developing and maintaining strong collaborations with individual Preclinical, Clinical and Pharmacovigilance functions.
Define and implement the GLP, GCP and GVP quality standard for Incyte Corporation including alignment of policies and procedures with US and International regulations.
Design and maintain Quality Assurance and GxP compliance for all aspects of Incyte's programs to support pre-clinical, clinical studies and future product registration.
Provide GxP Quality Assurance oversight of all external vendors' quality programs, including CROs, central labs, investigator sites, CMSOs, and other key partners supporting clinical programs, including maintenance of quality agreements.
Participate in establishment of new partnerships and Business Development initiatives.
Responsible for informing Senior/Executive management of compliance or quality risks and concerns.
Define key Quality metrics and perform periodic Quality management reviews.
Ensure business and compliance timelines associated with Preclinical & Clinical & Pharmacovigilance QA operational tasks are met.
Ensure Inspection readiness programs are in place and lead applicable regulatory inspections.
Point of contact with FDA for Quality matters in collaboration with RA.
Ensure GxP audit programs are developed, implemented and monitored for compliance with GCPs, GLPs, GVPs SOPs for the Research and Development organization. This includes the following functional areas: 1. Clinical (Medical, Clinical Operations), 2. Biometrics (Statistics, Programming, Data Management), 3. Pharmacovigilance/ Drug Safety, 4. Regulatory Affairs, 5. Medical Affairs.
Initiate and implement continuous quality improvement programs.
Apply Quality risk management.
In coordination with the Head of Global QA and peers within the Global Quality organization, work to develop and implement a common platform of quality and compliance systems, tools, and procedures and standards.
Provide Quality Assurance input to the Incyte global QA strategic goals in form of schedules, quality plans, and budgets.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's Degree in scientific/life sciences or related field required, higher degree preferred.
Minimum 15 years in Quality Assurance in a Pharmaceutical environment, with at least 7 years in leadership Pre-Clinical/Clinical QA and Global roles, international experience is an asset.
Knowledge of US, EU, ICH Regulations, Guidelines and requirements. Knowledge of GCP/GLP/GVP requirements.
Strong communication and influencing skills. Ability to present effectively internally and externally.
Prior success leading/managing /prioritizing multiple activities and projects; record of goal achievement/quality compliance, proven adherence to timelines and utilization of metrics to assess/improve performance.
Proven development of Quality personnel and expanding Quality organizational capabilities.
Prior success leading/managing /prioritizing multiple activities and projects; record of goal achievement/quality compliance, proven adherence to timelines and utilization of... For full info follow application link.
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