The Head of Quality Assurance is responsible for the strategic development and operational management of Cyteir’s quality assurance program. In addition, the Head of QA 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. As the leader of our Quality Assurance function, you will work collaboratively with other functional leaders to create and sustain a culture of innovation, efficiency, and balanced risk-management with an eye towards continuous improvement. You will be responsible for creating and sustaining a culture of Quality aligned with our company values.
- Lead the and drive the QA function in all GxP functional areas; including, for example, GxP SOP management & training, CAPA and deviation management, quality event or serious compliance breach issue support, change control, and secure document management.
- Establish, maintain and have oversight of the internal quality management system. Continually establish and improve quality systems, initiatives, priorities, and timelines.
- Ensures that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
- 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
- Ensure effective and comprehensive quality oversight of selected CROs and CDMOs
- Prepare the annual GxP audit and monitoring plan, including a risk-based audit and monitoring schedule and a CAPA effectiveness program; incorporate new audits as warranted for cause or for new vendors brought on board during the year.
- Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities
- 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.
- Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Senior Leadership.
- Update Quality Manual and lead Quality Management reviews with Leadership, including metrics to evaluate quality performance of the company and its CROs and CDMOs.
- Serves as an escalation point for corporate quality issues.
- 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.
- Establishes and ensures quality metrics comply with best industry standards and practices.
- 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.
- Breadth and depth of knowledge in GxP quality standards and regulations during all phases of development (pre- and post-market), particularly GMP, GCP, and GLP
- Experience in developing, implementing, and maintaining Quality Systems
- Team player with executive presence, stature, credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal and external stakeholders.
- Strong history of leading others to success and a good reputation for building and managing high performance teams.
- As a change agent, motivated to improve the organization and not be satisfied with status quo.
- Strong intellectual curiosity and pursuit of knowledge. Cultivates new ideas. Comfortable with ambiguity and uncertainty.
- Must have good judgment and ability to take prudent risks.
- Good critical thinking skills able to define, analyze and propose alternative solutions, assisting in resolving complex issues.
- Demonstrated experience raising issues and constructively challenging the organization to drive change.
- 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.
*Cyteir Therapeutics requires all employees to be fully vaccinated against COVID-19. This requirement is a condition of employment at Cyteir. If you are unable to receive the vaccine due to a serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.