Senior Director/Director of Quality Assurance
The Senior Director/Director of Quality Assurance is responsible for the strategic development and execution of Cyteir quality assurance program and is accountable for the development, execution and administration of the GXP Quality Systems to support GMP, GLP, and GCP compliance in accordance with ICH, US and EU regulations. This position is expected to lead the quality function and collaborate across the organization on global quality matters.
- Ensures that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
- Establishes and ensures quality metrics comply with best industry standards and practices.
- Maintains an effective Quality governance and continually improves governance to meet business and compliance needs.
- Ensures overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical. Determines applicable quality standards and regulations and provides guidance and quality oversight to ensure ongoing compliance
- Establishes strong working relationships with external manufacturers of our products and assures alignment of our Quality Systems and requirements with CDMOs. Ensures products manufactured at CDMOs meet company quality standards and government regulations.
- Establish, maintain and have oversight of the internal quality management system. Continually establish and improve quality systems, initiatives, priorities, and timelines.
- Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities
- Provides appropriate Quality oversight of external vendors (CMOs, CROs, etc.) including establishing vendor qualification processes, vendor audit plans, quality agreements and quality performance metrics.
- Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project, business and quality needs are met.
- Keeps abreast of industry developments, forthcoming regulations, guidance, best practices etc.
- Counsels, trains and interprets quality requirements to ensure the company and the GxP vendors maintain a state of compliance with quality and regulatory requirements.
- Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Senior Leadership.
- Serves as an escalation point for corporate quality issues.
- Lead SOP development activities and updates
- Oversee the CAPA process and vendor management for quality issues
- Manage business administration of computerized Quality Management Systems, with emphasis on document control and training systems
- Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls
- Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
- Develop, implement and oversee training programs to ensure compliance with GxP and ICH requirements.
- Lead inspection readiness and PAI activities
- Minimum of BS, MS or PhD in a relevant technical field.
- 15+ yrs. of relevant work experience in pharmaceutical QA required.
- Solid and demonstrable knowledge of GxP regulations, guidelines and experience implementing QM systems.
- Familiar with ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice.
- Attention to detail with an ability to perform critical review of pharmaceutical development and manufacturing documentation.
- Strong organization and time management skills.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Ability to independently solve problems and work cross-functionally.