The QA Consultant will provide hands on leadership for coordinating and managing the day-to-day activities of the Quality Assurance department as the QA organization moves from clinical GMP manufacturing, through validation, regulatory submissions, and into commercialization. The right candidate will have the depth of GMP Biologics experience, (immunotherapy is desirable), regulatory knowledge and ability to prioritize and be comfortable in executing daily operational tasks.
With guidance from Vice President of Quality, the Director of Quality Assurance will be responsible for the development and maintenance of Quality systems to insure compliance to GMPs and other applicable regulations.
- Manage and provide quality oversight for GMP QA Operations including review of batch records for manufacturing and labeling/packaging operations to insure timely batch release of clinical trial materials (CTM) for clinical trials.
- Ensure products are manufactured and tested and dispositioned in compliance with SOPs and applicable regulations.
- Partner with contract service providers and CMC to insure timely closure of deviations, OOS, investigations, complaints, and implementation of appropriate corrective actions. Drive science-based decisions
- Provide Quality management for outsourced activities at external contract service providers (CSP) including contract manufacturers and contract testing laboratories.
- Establish and maintain Quality Agreements with CSPs.
- Review and approve GMP documentation such as batch records, analytical test methods, process and method validation protocols and reports, stability data product specifications and change controls.
- Establish and maintain quality assurance policies, procedures and controls to meet quality and regulatory requirements.
- Contribute to the preparation and review of CMC sections for IND and BLA submissions.
- Develop and implement quality metrics to drive continuous improvement.
- Develop audit plans and conduct internal and external audits to insure vendors are appropriately qualified.
- Ensure that all quality trends are evaluated, that root causes are identified and corrective actions are implemented.
- Support/lead regulatory agency inspections.
EDUCATION AND EXPERIENCE
- BS/MS in Life Sciences with 10+ years experience in Biologics/Biotech industry. Must be a scientific/technical expert. Advanced degree is a significant advantage.
- Strong track record in providing QA/QC oversight for outsourced Biologics manufacturing setting for clinical/commercial products.
- Immunotherapy is a strong plus
- Thorough knowledge of biologics pharmaceutical development
- Demonstrated ability to strategize, prioritize and communicate effectively.
- Sound knowledge of FDA and EU regulations and ICH guidelines.
- Strong attention to detail, excellent review skills, strategic thinking and effective communication.