Sr. Director, Global Preclinical & Clinical QA

Proclinical is seeking a Senior Director of Global Preclinical and Clinical QA for a leading pharmaceutical company located in Wilmington, DE. The Senior Director, global Preclinical & Clinical QA lead and manages 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.

Job 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.
• 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.

Skills and Requirements:

• 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.
• Strategic mindset
• 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 metrics to assess/improve performance.
• Proven development of Quality personnel and expanding Quality organizational capabilities.
• Ability to travel domestically and globally as needed.

If you are having difficulty in applying or if you have any questions, please contact Jason Lawrence at (+1) 646-779-7968 or j.lawrence@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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