The Site Quality Head is responsible for leading the Quality Assurance and Quality Control divisions at the site and for ensuring site compliance with applicable regulations and meet business needs. This position’s responsibilities include but are not limited to overseeing of the site quality, establishing and maintaining a risk-based and science-based quality system, ensuring implementation of quality policies and standards, driving continuous improvement activities based on the evolving regulatory requirements and industry best practices.
MAJOR DUTIES AND RESPONSIBILITIES
- Lead the Quality Assurance and Quality Control divisions at the site providing leadership, guidance, and mentorship.
- Direct the Quality Assurance department. This includes but is not limited to being responsible for the disposition of GMP materials along with the QA associates, overseeing and assisting with the site training and auditing programs, SOPs revisions, investigations, validations, approval of specifications and methods, review of data and manufacturing records, supplier qualifications.
- Oversee the Quality Control department ensuring that the highest standards of quality, compliance and technical excellence are maintained and that the business needs are consistently met maximizing productivity and efficiency.
- Establish and maintain a risk-based and science-based quality system which meets the most current regulatory requirements and industry standards and is compliance with corporate quality policy and standards.
- Ensure all site GMP operations are in compliance, while maintaining an efficient workflow to facilitate the operational excellence.
- Collect, monitor, and report quality key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality, productivity and efficiency of the QC and QA departments and of the site.
- Act as primary point of contact during inspections by regulatory authorities and support customer audits. Implement inspection-readiness programs and ensure that proper CAPAs are prepared and completed on time.
- Support global quality and continuous improvements initiatives.
- Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide.
- Effectively communicate with internal and external customers making sure that the values and business goals are consistently achieved.
QUALIFICATIONS
- BS./B.A. or M.S. degree in Chemistry or related field.
- At least 10 years of experience in the pharmaceutical industry, with at least 8 of those years being experience in Quality Assurance and at least 5 of supervisory experience.
- Additional experience in QC is preferred.
- Understanding of the most common QC analytical techniques applicable to APIs (i.e. chromatography, polymorphism, particle size, wet chemistry)
- Strong knowledge of the pharmaceutical industry regulations applicable to API manufacturers.
- Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal.
- Strategic thinking.
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