Director of Quality Assurance
- Experience Level
Director Quality Assurance, New York City
About the Company:
As a recognized leader in targeted radioimmunotherapy and targeted conditioning for bone marrow transplant, my client is rapidly building and advancing a robust portfolio of promising drug candidates for both hematologic malignancies and solid tumors. We are seeking a Director of Quality to oversee, lead and direct all quality activities within the Company and with our CMO partners. The ideal candidate is a skilled leader with at least 8 years’ experience leading quality organizations who can make an immediate impact within an energetic and collaborative team building off her/his extensive experience managing quality for development products in GMP and GCP in the biotechnology or biopharmaceutical industry.
About the Role
The Sr. Director Quality is responsible for all quality assurance systems and the implementation of relevant corporate policies, procedures, and training across the company. He/She will ensure that internal processes and metrics and those of our CDMOs and CTOs are aligned to create a high level of product quality and consistency. This includes: Quality Assurance, Quality Control, GxP Compliance, GxP Training, Validation QA, and Document Control. Prior Quality experience in biotech or pharmaceutical industry, particularly biologics, is essential. Prior experience directing quality teams in radiopharmaceuticals is a plus.
The Director of Quality will be responsible for ensuring alignment of the quality function to product development, manufacturing, clinical, and other areas as required and will establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness. Collaborate with all departments within the Company to ensure that quality standards and GxP compliance are met and maintained. Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
- Provides strategic and operational management of the Quality Assurance/Quality Control team
- Responsible for the overall site Quality Systems execution and management of deviations, CAPA, change control and risk management activities, and ensuring adherence to applicable GMP regulations
- Responsible for establishing and maintaining high level performance within the quality team and across the organization
- Accountable for ensuring adherence to strict regulatory requirements to ensure product quality
- Provides leadership for and ensures the effective transfer of analytical methods to CDMOs and CTOs to support pre-clinical and clinical activities
- Builds and maintains relationship with drug substance and drug product CMO manufacture quality teams and with analytical testing partners
- Reviewing completed batch production and laboratory control records of critical process steps before release of the products for distribution
- Reviewing and approving validation protocols for analytical methods, manufacture process and their reports.
- Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings.
- Ensures that quality-related complaints are investigated and resolved
- Ensures adherence to timelines in support of all regulatory filings
- Plans and direct vendor audits and work with vendors and production support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.
- Responsible for GxP/GCP training of CMC/Clinical staff
- Expert level knowledge of cGMP requirements as they pertain quality control testing of biopharmaceuticals
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
- Team oriented and able to manage multiple projects across various development stages.
- Excellent oral and written communication skills.
- Small company and/or start-up experience.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
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