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Senior Director, Global Quality
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At Proclinical, we are seeking an experienced individual to fill the role of Senior Director of Global Quality, based in Boston, MA. The successful candidate will be responsible for overseeing the Quality Assurance and Validation departments.
Responsibilities
- Develop, implement, manage, audit and maintain GXP quality systems to support commercial and development activities.
- Coordinate and perform all vendor qualification and compliance audits.
- Perform lot release activities, including lot file compliance review.
- Oversee Quality Control activities performed by contract testing laboratories and contract manufacturing companies.
- Develop, manage and maintain a GXP compliant document control system.
- Oversee investigations of all non-conformances (deviations, OOS).
- Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
- Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines.
- Ensure a maintained state of readiness for inspection by regulatory agencies.
- Lead quality efforts in corporate development of analytical methods.
Skills And Qualifications
- BA/BS in relevant field and 15+ years relevant experience.
- Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU GMP requirements.
- Exceptional written, verbal, and interpersonal communication skills.
To Apply:
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 Matt Tong at (+1) 6468786308 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.
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