Director, Gmp Quality Management
2 weeks ago
**About Morphic Therapeutic**
**Essential Job Functions**:
- Responsible for end-to-end Quality oversight for clinical manufacturing, quality control and disposition of drug substance, drug product and labeled drug product. Review Reports, Methods, Master Batch Records, Specifications and Executed Batch Records for small molecule drug substance, drug product, and final labeled drug product.
- Provide strong technical leadership in support of activities governed by global current Good Manufacturing Practices, (cGMPs) and ensure compliance with all applicable regulations and guidelines.
- Oversee the review and disposition of IMP for each stage of manufacture (Drug Substance/ API, Drug Product, and Finished Good) from Contract Manufacturing Organizations (CMOs); perform QA release of IMP in all US/Ex-US regions.
- Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for clinical manufacturing, release and distribution of quality product meeting all relevant regulatory requirements, applicable standards and guidance.
- Collaborate with Technical Operations and GMP contract service providers to evaluate and address complex issues such as deviations, OOS/OOTs, corrective and preventive actions (CAPA), change control, and failure investigations. Lead evaluation and escalation (as appropriate) of product quality issues.
- Work with CMC to develop material, product, and process specifications.
- Provide Quality Support to internal and external Change Controls assessing product quality and regulatory impact; Provide Quality support for deviations, complaint investigations, and OOS/OOTs, assessing for product quality and program impact, and partner with internal and external stakeholders to drive issue resolution and CAP A identification and ensuring timely closure.
- Participate in internal audits to identify areas for improvement and collaborate with stakeholders to implement effective and sustainable corrective measures.
- Review and verify data to assure compliance with data integrity and traceability regulatory requirements, as appropriate.
- Coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.
- Provide Quality review of regulatory filings and ensure compliance with regulatory requirements.
- Establish and maintain quality oversight of GMP vendors including participating in design and execution of vendor assessments, establishing/monitoring compliance to Quality Agreements, and utilizing quality metrics to track vendor performance.
- Generate, track, and trend Quality Systems compliance metrics and compile metrics and information to produce Quality Management Team reports.
- Author, review, and/or approve Policies, Standard Operating Procedures (SOPs) Work Instructions (Wis), and supporting documentation related to GMP activities.
- Continuously improve and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards.
- Organize and promote company-wide quality systems continuous improvement programs. Evaluate and develop improved systems and processes for the control of quality, reliability, and safety of investigational products.
- Monitor industry trends and current regulatory expectations to ensure evolution of the GMP Quality Management System and compliance strategy.
**Qualifications**:
Required
- B.S. in science or related discipline required, advanced degree preferred
- 10+ years of experience in the biotech/pharmaceutical industry, with 5+ years of experience in a GMP Quality Assurance function and experience managing contract vendors.
- In-depth knowledge of cGMP standards, policies, and procedures (domestic and international). Expertise with interpreting and implementing GXPs, FDA, EMA, PMDA, and ICH Regulations and guidelines and experience reviewing submission documentation and preparing responses to regulatory inquiries / inspections.
- Experience working with IMP in global clinical trials across all phases of development.
- Experience and strong understanding of small molecule drug substance and nonsterile oral solid dosage drug product manufacturing
- Experience working with external CDMOs and/or CTLs for Drug Substance, Drug Product, and Finished Product
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
- Possess strong conflict management and negotiation skills.
- Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with mínimal supervision
- Highly collaborative, with excellent organizational, communication (written and verbal), and interpersonal skills
- Demonstrated success in preparing for and managing regulatory interations
- Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets
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