Director, Quality Assurance
3 weeks ago
Title: Director, Quality Assurance (Drug Substance)
Location: South San Francisco, CA
Hybrid: 3-4 days a week onsite
Compensation: Annual Salary of $230,000
Annual bonus of 20%
plus equity in shares of options
We are seeking an experienced professional to join our team as Director, of Quality Assurance.
Qualified candidates must have worked directly with small molecules in the past, and have successfully taken late-stage NDAs from clinical trials to commercialization.
This role will provide oversight of drug substance contract service providers (CSPs), develop and review quality agreements, lead batch disposition activities and support future commercialization. The candidate should have strong hands-on experience with developing, implementing, maintaining, and improving Quality System procedures using risk-based principles to ensure adherence to regulatory and Pliant requirements.
Required skills
- Responsible for the disposition of drug substance, including review of master and executed batch records, specifications, certificates of analysis and analytical test data (in-process and release) for manufacturing and testing conducted at CSPs.
- Review and approve validation protocols/reports (e.g., process, method), analytical test methods, reference standard, stability protocols/reports and establishment of shelf-life.
- Support commercialization activities, including process validation, technology transfer, packaging validation, serialization and third-party logistics.
- Support the development, implementation, and enhancement of Quality Systems including disposition, vendor management, deviations, change control and CAPA.
- Perform review and closure of internal and CSP generated deviations (including OOS and OOT), change controls, and CAPAs, ensuring timely escalation and notification to leadership and compliant resolution of product-impacting quality issues.
- Provide Quality support for temperature excursions.
- Establish and ensure adherence to Quality metrics, effectively communicate status and provide strategic recommendations and improvement actions to Senior Management.
- Participate in Quality Management meetings such as Material Review Board and Quality Management Review.
- Contribute to development and revision of Quality Agreements.
- Collaborate on supplier qualification and management including supplier audits, as needed.
- Participate in internal and external inspection readiness activities.
- Contribute to CMC sections of regulatory submissions as necessary.
- Build and foster a quality mindset within Quality and throughout the company by ensuring consistent, risk-based process are employed in decision making.
Qualifications
- BS/BA degree or MS degree in a scientific discipline with at least 10+ years of pharmaceutical or biotechnology industry cGMP experience including 5+ years of experience in positions of management responsibility within Quality Assurance.
- Strong knowledge of cGMP, ICH, FDA, and EU regulations.
- Direct experience working with CSPs within the US and globally to meet disposition timelines.
- Prior global commercial experience, including process validation, packaging validation and serialization.
- Exercise sound judgement ensuring that written procedures are followed with proven ability to drive quality process improvement initiatives.
- Understanding of risk management principles and the ability to develop and implement risk mitigation plans related to product quality and safety.
- Highly collaborative team player who fosters open communication and facilitates cooperation between stakeholders.
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