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 Schrödinger, 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 both partnered and 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 AstraZeneca 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.
We are seeking an experienced GCP Quality Management (Quality) professional who is a resourceful and integrative thinker for a highly visible role to establish the vision and implement the strategy for the Clinical Quality function. This person will be the internal GCP expert within Quality Management. This professional’s responsibility includes the development, execution and maintenance of risk-based audit strategies focused on internal and external Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, company procedures and clinical trial protocols. This person will be responsible for establishing and maintaining global standards for GCP compliance and working where appropriate to meet other compliance requirements as part of a Quality team.
In particular, this person will be responsible for deploying comprehensive GCP inspection readiness plans which requires participation in and management of a cross-functional team of company colleagues and the development, maintenance and continuous improvement of departmental processes and procedures and support of the implementation and continuous improvement of GCP systems. This position fosters and promotes a GCP compliant environment with internal and external stakeholders. The GCP QM professional is responsible for the management of people, including contracted consultants, and is expected to exhibit exemplary organizational and leadership values, including leading by influence.
Essential Job Functions:
Responsibilities include, but are not limited to:
· Establish the vision and implement the associated strategy for the Clinical Quality Management function
· Proactively provide GCP support to the clinical study teams in minimizing potential risks and providing solutions to compliance gaps.
· Manage and/or participate in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determine compliance status and identify compliance risks.
· Institute comprehensive GCP inspection readiness plans for regulatory authority inspections. Conduct the GCP inspections. Direct the development of adequate and appropriate responses and resolutions to identified observations. Drive timely completion of the agreed corrective and preventive actions.
· Identify, communicate, and escalate GCP corporate risk and serious non-compliance situations and follow to resolution, acting at all times with an appropriate sense of urgency
· Establish effective means for communicating audit and inspection outcomes, developing metrics, measuring trends and driving improvements thus identified
· Ensure policies and/or procedures within clinical research, such as Clinical Development, Clinical Operations, Biostatistics, Pharmacology, Translational Biology, Bioanalytics and other departments, are adequate to achieve the goal of building quality within clinical research programs and activities, particularly focusing on a risk-based approach.
· Perform detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs and other essential documents prior to their Quality Assurance acceptance or approval.
· Oversee company-wide GCP training.
· Continuously remain up-to-date with the latest industry changes with regulatory requirements, industry standards and provide consultancy on quality/ compliance/ regulatory related issues.
· Represent GCP Quality Management on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives, particularly those related to application of new and revised industry standards, guidelines and regulations within all affiliated areas of GCP.
· Act as a champion for the effective use of the quality systems (training, procedures, internal deviations, CAPA) within the various clinical research and associated support functions.
The candidate must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, experience developing strategic and long-term relationships with key stakeholders, tested conflict management and negotiation skills are required. The ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is required. Demonstrated ability to translate strategy into action, excellent analytical skills, an ability to communicate complex issues clearly to a broad group of people and experience orchestrating plans to resolve issues and mitigate risks.
• Bachelor's degree in life sciences, pharmacy, or nursing; advanced Life Sciences Degree or MBA preferred
• Minimum 10 years in Quality Assurance with experience in GLP, GCP, GVP and GMP
• Minimum of 10 years auditing experience
• Proficiency with interpreting and implementing GXPs, FDA, EMA, PMDA, ISO and ICH Regulations and guidelines
• Experience with reviewing submission documentation, and responses to regulatory inquiries / inspections
• Preferred experience with Phase 2 to 3 stage product development and experience
• Demonstrated success in preparing organization for pre-approval inspections by FDA and other regulatory agencies
• 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
• Success with anticipation and prevention of long-range problem solving, including proven track record of industry success
• Preferred experience with outsourced manufacturing and testing operations
• Ability to work collaboratively across departments
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, SharePoint and Project
• Embraces Morphic core values
• Occasional travel may be required (15-20%)