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Associate Director, Quality Systems
2 months ago
FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.
FOG-001, the company's first-in-class TCF-blocking ?-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.
What's the opportunity?
This position is responsible for managing FogPharma's quality systems in compliance with all regulatory requirements. This is a hands-on position applying quality assurance principles to the design, validation, implementation and management of FogPharma's systems including but not limited to quality related records and training.
Responsibilities:
- Ensures functional budgets and resource targets are assessed and managed to enable departmental targets to be achieved.
- Establish and manage Quality Management System to ensure visibility to quality and compliance to:
- Document Management System
- GxP vendor management system
- Oversight of the electronic document control and training systems
- Quality Management Reviews
- Collection and reporting of quality metrics
- GxP Computer System Validation
- Administer GMP training program, conduct training sessions as required and maintain training database for all GxP functional areas.
- Serve as the Quality Assurance representative for GxP computer systems projects.
- Provide leadership and oversight of the QA Validation process for FogPharma's
- Provide guidance, interpretation and information pertaining to current GxPs to apply updates to the Quality System.
- Monitor and inform others of changes to established quality systems standards, regulations and guidances. Provide consultancy on related quality/compliance/regulatory issues.
- Lead preparations for/Host internal/third-party/regulatory inspections, including assisting in preparing audit reports and responses to observations, providing recommended conclusions and actions with implementation.
- Ensure appropriate responses and resolutions to quality system related inspections/audit findings are agreed and implemented.
- Resolve complex and unique quality systems issues pragmatically, yet compliantly.
- Participate on cross-functional teams to support relevant quality requirements.
- Responsible for implementing processes to support the management of documents within the Technical Operations group. Both manual processes and using the QMS electronic Document Management System.
- Coordinate and support the creation of, revisions to Standard Operating Procedures (SOPs), Policies, and overall management of document hierarchy.
- Promote the recognition of quality programs within the company to create a shared continuous improvement mind-set across functional departments and reinforce continuous improvement principles.
- Establish and monitor global compliance processes (CAPA, Deviations, Field Actions, Change Control)
- Provide long range strategic planning of Quality System related activities.
- At least ten years experience in a quality role within a pharmaceutical development or manufacturing setting is required. A bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering or related scientific discipline is expected. An advanced degree is desirable.
- Minimum of three years direct management level experience is necessary.
- Areas of expertise: Quality, Compliance, GxP, Regulatory.
- Outstanding leadership, organizational and interpersonal proficiencies.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, service provides and contractors.
- Strong technical and analytical skills to identify and solve problems appropriately.
- Demonstrated project management skills, with the ability to coordinate multiple projects in a demanding fast-paced environment.
- Working knowledge of drug development processes and associated FDA/EMA/ICH regulations and guidelines.
- Operational knowledge of drug lifecycle management and drug commercialization processes and associated industry standards.
- Demonstrated ability to define and implement procedures, which ensure compliance to GxPs (particularly GMP, GDP, GCP and GVP).
- Ability to exercise independent judgment in making decisions to assure quality and compliance.
- Working knowledge of validation as applied to computer systems.
- Demonstrated audit conduct and management experience is required.
- Ability to travel approximately 20% on average, including trips abroad.
FogPharma is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.
- Creative. We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.
- Humble. We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.
As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
30 Acorn Park Drive | Cambridge, MA 02140 | www.fogpharma.com
