Sr. Director, Global Preclinical & Clinical QA job in Wilmington, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)

Location: United States

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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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