Director, GMP Quality Management

Waltham, MA, United States

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrdinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

Morphic is advancing fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.

Job Description:

Morphic Therapeutic is seeking an experienced and collaborative Quality professional who will support GMP operations across Morphic's development programs. The Director, GMP QM will work within a phase appropriate system to provide quality oversight for manufacturing and supply chain for all investigational products to ensure patient safety and compliance with FDA and other applicable global health authority requirements. This role applies technical knowledge and quality expertise and works collaboratively with Morphic's Technical Operations team to establish internal product and process specifications, proactively identify issues and risks and propose mitigations and solutions, provide QA oversight with contract manufacturing organizations, evaluate the impact of quality events, lead quality related investigations, and provide quality guidance to the internal organization. The qualified candidate will have experience in building and maintaining sustained and trusting relationships with key strategic internal and external stakeholders, including the ability to aid in the growth of the Quality function to support development programs from preclinical to commercial phases. The position will report to the Sr. Director, Head of Quality Management and will be based in Waltham, MA.

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 minimal 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 for maintaining a state of compliance while identifying areas for improvement

•Anticipates potential issues and implements remediation and mitigation strategies; works collaboratively with teams toward the most effective solutions

•Occasional travel may be required (15-20%)

Cultural Fit:

Our culture is collaborative, one where people enjoy coming to work. We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done. Our team is passionate, enthusiastic, and committed. We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor. We seek an individual for this position who shares our values and our enthusiasm about

bringing new medicines to the patients and families that need them. We seek someone who will enjoy working in a small company environment and be motivated by the opportunity to directly influence and help shape the future direction and culture of our company.

Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees' development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients' lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.

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