Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Director, Quality Operations.
Major tasks and responsibilities will include: Provides leadership and strategic direction to the Quality Operations team. Assists in developing and driving process validation strategies. Assists in the development and/or revision of GMP quality processes. Manages the development, review, and approval of lifecycle validation master plans, protocols and reports. Leads and manages quality with external vendor partners. Ensures vendor metrics are accurate and tracks improvements. Oversees execution of GMP audit plans, reviews reports, and tracks corrective actions. Leads or participates in Quality Risk Assessments. Contributes to commercial readiness preparations internally and at GMP vendors. Acts as a subject matter expert for QA oversight of GMP operations during audits and regulatory inspections. Participates on interdepartmental program and leadership teams.
We seek candidates with the following qualifications: Bachelors degree in Life Sciences, Chemistry, Engineering or equivalent required. Must have 10 years of relevant pharmaceutical industry experience and complete understanding of regulatory guidances and industry practices for product lifecycle. Experience in all clinical phases through commercialization highly preferred. Experience leading and/or facilitating risk management activities required. Requires experience with Pre-Approval Inspections. Must be willing, and able, to travel domestically and internationally up to 20%.
If interested, please email your resume as a Word attachment to us, reference 3783. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlons list of Top 50 Healthcare & Life Sciences Search Firms.
Associated topics: administrative officer, administrative support, assistant, document, facilities, front desk, operation, operational assistant, operational support, staff