Director, QA - Head of QA
Director, Quality Assurance
A clinical stage, immuno-oncology company developing next-generation immunotherapies is hiring. We are committed to pioneering the development of novel cancer immunotherapies in order to bring meaningful and long-lasting clinical benefits to patients.
We are seeking a Director of Quality Assurance to develop quality systems, support regulatory efforts, and lead the Quality Assurance dept.
- Supports the build of the Quality System to ensure regulatory and industry standards are met.
- Independently initiates and manages the review and approval of SOPs in compliance with applicable regulatory requirements, and supports department infrastructure development
- Reviews batch records and sets expiry
- Provides strong guidance, interpretation, and information pertaining to current GMPs, GCPs and GLPs to apply updates to the Quality System including SOPs, Policies and Specifications.
- Supports GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.
- Devises GxP auditschedule, oversees execution of audit plans and audits, reviews auditreports, and tracks corrective/preventive actions associated with key sites and contract service providers in accordance with applicable regulations, guidelines and SOPs.
- Ensures that all required aspects of the Quality Management System are trended on a routine basis for presentation to senior management for review
- Manages the internal audit programs.
- Manages contractors/consultants
- Ability to grow out the Quality Assurance function to support development of candidates from pre-clinical to commercial.
QUALIFICATIONS AND EXPERIENCE:
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Bachelor’s degree with minimal 10years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems managerial roles, GLP and GCP experience a plus.
- Possess in-depth knowledge of GMP/GLP/GCP regulations, principles, concepts, industry practices and standards.
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
- Understanding of domestic and international regulatory requirements.
- Outstanding communication skills (interpersonal, verbal and written).
- Proven track record of industry success.
- Strong leadership and management skills.
- Excellent teamwork and collaboration skills.
Quality Assurance, Regulatory Compliance, GMPs, cGMPs, 21 CFR part 210, 211, 600, 601, 610, current good manufacturing practices, antibody, antibodies, vendor quality management, CMO, contract manufacturing, outsourced production, oncology, quality management systems, QMS, team development, auditing, quality operations, batch record review, monoclonal antibodies, mAb