Our client is aclinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Quality .
Major tasks and responsibilities will include :
Oversees both Quality Assurance and Quality Control functions across all GXP processes.
Liaises with regulatory agencies in regard to GXP matters.
Works to improve our current quality management systems and to establish Strategic Quality Objectives in support of development programs and company goals.
Develops and maintains internal and external audit programs in order to satisfy contractual and regulatory requirements for GXP.
Identifies and implements scalable software to support Quality systems.
Coordinates the Quality review of documents for regulatory submissions.
Oversees pre-approval inspection readiness.
Develops and reviews qualification and validation plans and reports.
Enhances Quality Systems processes, including CAPA, Change Control, Document Control, Risk Management, identification of Critical Quality Events, etc.
Establishes training programs for GMP, GCP and GLP.
Manages and develops Quality Systems staff.
Promotes Quality culture across functions.
We seek candidates with the following qualifications:
Bachelor's Degree in Biological sciences, engineering or related field is required. Advanced degree is highly preferred.
Must have a minimum of 15 years of pharmaceutical industry experience, including 5 years of experience in a supervisory capacity.
Requires experience in all phases of drug development.
Experience with cell therapy or novel modalities highly preferred.
Full range of QA experience in GMP and GCP is required. GLP knowledge highly preferred.
Requires knowledge of current GXP qualification and validation expectations.
Must have demonstrated hands-on leadership skills, with the ability to perform lot release, data review, laboratory and facility audits.
Must have experience with European quality guidance and Qualified Persons (QP) requirements.
Requires practical knowledge of implementation of I CH Q10 Quality Systems, especially Risk Analysis/Management, CAPA, Annual Product Reviews and Management Review and Supplier Quality Management.
If interested, please email your resume as a Word attachment to us, reference 4189. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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