As part of a talented and multi-disciplinary team advancing exciting new approaches to drug development, Stemcentrx is looking for a highly motivated individual to join our Quality Assurance Department. The Associate Director of Quality Systems and Compliance will be responsible for managing and maintenance of compliant and efficient GMP quality systems and procedures related to the manufacture, testing, and disposition of antibody drug conjugate products manufactured in Stemcentrx’ in-house manufacturing facility. Quality systems include Change Control, Deviations, CAPAs, Document Control, the GXP Training Program, the Vendor and Internal Audit Programs and the Management Reporting Program. Implementation of an Electronic Quality Management System will also be the responsibility of this position. In addition, this position will be responsible for overseeing the internal and external audit programs (including supplier qualification), the latter in collaboration with colleagues in AbbVie R&D QA.
Duties and Responsibilities:
• Implement and maintain systems, programs and processes to ensure compliance with GMP Quality functions through Phase 1/2 clinical manufacture at Stemcentrx’ internal manufacturing plant.
• Write and revise compliant Quality SOPs.
• Manage deviations, CAPAs, complaints, change controls, and document management per the Stemcentrx Quality Management System to comply with applicable company, US and EU regulatory requirements.
• Partner with the functional areas of Manufacturing, Facilities, QC, and Engineering to drive closure of Deviations, CAPAs, Investigations, Complaints, and Change Controls.
• Ensure that all required aspects of the Stemcentrx Quality Management System are trended on a routine basis and presented to senior management for review.
• Drive continuous improvement efforts of the Stemcentrx Quality Management System
• Maintain the GXP Training Program and provide training related to Stemcentrx quality procedures, US and EU cGMP regulations and guidelines.
• Partner with IT to manage the implementation, validation and oversight of an Electronic Quality Management System (EQMS)
• Manage the internal and external audit programs. Collaborate with colleagues at AbbVie R&D QA on supplier qualification.
• BA or BS degree in a scientific discipline. At least 12 years’ experience in Quality Assurance at an operational level supporting quality systems and compliance in a pharmaceutical or biotech environment.
• In-depth knowledge of pharmaceutical cGMPs (US and EU).
• Proactive in identifying opportunities to streamline operations along with strong problem solving and negotiation skills.
• Highly collaborative with the proven ability to work in cross-functional teams.
• Able to work independently on QA projects and initiatives with minimum supervision.
• Able to work hands-on in an entrepreneurial, fast paced environment.
• Strong verbal and written communication skills and computer skills are required.
• Must be goal-oriented, quality-conscientious, and customer-focused.
• Prior experience with antibody drug conjugates and/or managing computer system validation projects would be a plus.