Director, Global Quality Management Systerm
Proclinical is currently recruiting for a Director of Global Quality Management System for a pharmaceutical company located in Philadelphia, PA. Successful candidate will maintain and enhance the company GxP Quality Management System to ensure alignment with the company business operations and to comply with applicable regulations and standards of practice.
- Lead the development, maintenance and oversight of the global Quality Management System (QMS) that includes - Quality Manual, Quality Policies, Global Quality Standards, electronic platforms and SOPs.
- Ensure that the QMS is maintained in accordance with current regulatory compliance requirements and meet current corporate quality and business objectives.
- Develop and conduct the global GxP and Quality assurance training program, Inspection readiness program and the Internal GxP audit program.
- Coordinate and conduct periodic Quality Management reviews and chair the Quality Council.
- Define, compile and report quality performance and compliance metrics.
- Develop, establish, write and implement key Quality Assurance SOPs and Forms as necessary.
- Promote Quality and GxP awareness across the organization including training initiatives and the development and maintenance of the Quality intranet web site.
- Develop global Quality plans with Compliance related objectives.
- Interact effectively with company management, internal departments and other sites to effectively implement and maintain the company Quality Management System.
- Manage effectively the QMS staff and promote cross-functional team values, mentorship and lead by example.
- Develop and establish Global Quality Risk Management program including applicable tools.
- Lead Global QA cross-functional continuous quality improvement initiatives.
- Organize and conduct the Global GxP regulatory Watch Process to Monitor Emerging regulations impacting the Company QMS.
Skills and Requirements:
- Bachelor's degree or higher required, preferably in a scientific discipline.
- 10+ years in Quality Assurance in a Pharmaceutical environment with a Global role, international experience is an asset.
- 5+ years' experience in a pharmaceutical Quality Management System role.
- Knowledge of US, EU, ICH Regulations, Guidelines and requirements.
- Knowledge of GCP/GLP/GMP requirements associated with clinical development, product manufacturing for use in clinical trials and commercial distribution.
- Ability to travel domestically and globally as needed.
- Functional understanding of the drug development life cycle from discovery through post approval.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.