Wayne Metro Area, NJ
Manages quality programs to improve total quality of company product and processes. Oversees implementation and compliance with ISO and other applicable quality standards. Researches, analyzes and reports quality trends and other data.
Leads teams of cross-GxP SMEs across the Development Quality function in holistic quality assessment of In-licensing , Divestment and out-Partnering deals.
Leads in a matrix a cross functional QA team to evaluate external opportunities ensuring robust, fair balance, and timely due diligence recommendations
Ensures effective and inclusive quality assurance oversight for BD&L projects and manage integration of QA oriented activities such as QA due diligence visit in collaboration with BD&L due diligence heads and/or managers, representative from clinical, pharmacovigilance, technical development and audit & compliance.
Facilitate timely decision making by QA Management (Line functions) based on recommendation from QA SMEs and business evaluation.
A minimum of 8 - 10 years of experience working in the Pharmaceutical Industry, preferably in Quality and/or Clinical Development; strong background and experience in cross-GxP (GCP, GVP, GLP, GMP) regulations.
A minimum of 8 years of experience working in a GxP regulated area (preferably including GMP technical and GCP), with broad understanding of global expectations of Health Authorities in the area of Global Drug Development.
Past contribution to in-licensing, M&A and due diligence; extensive experience is preferable
Strong management, interpersonal, communication, negotiation and problem solving skills.
Proven ability to network and collaborate with business partners.
Strong written and project management skills.
Considerable organizational awareness (e.g. inter-relationships of departments, business priorities), including significant experience working cross-functionally and in global teams.
Strong, in-depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project); strong experience with standard quality system tools e.g., Track wise, is preferable.
Sound judgement of which risks and issues need to be highlighted and properly communicated to (senior) management.
Bachelors of Science degree in any one engineering discipline. Advanced life sciences degree and/or MBA preferred