Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
The GxP QA Document Manager/Sr. Manager role is part of a highly motivated QA team and provides opportunities to cross train and enhance skills in the GxP areas. The successful candidate will be a key contributor to the departmental objectives and support the management of key corporate milestones.
S/he will support existing and new clinical programs as a key member of the QA organization. S/he will collaborate with and provide guidance to cross functional teams to maintain and optimize a phase appropriate quality system for the conduct of clinical studies and oversight of CROs. Responsibilities include supporting the optimization of the Quality Management System as well as supporting other QA members with clinical study oversight, vendor audit management, Document management, and GxP training.
Specific responsibilities include:
Clinical Studies Support
- In collaboration with Director of GCP QA:
- Support the clinical study teams with the management of Quality Events and/or CAPAs that are identified and/or being managed internally, by external vendors or at the clinical investigator site(s)
- Review study level plans (Clinical Monitoring Plan, Safety Management Plan etc.)
- Support the clinical study teams with management of study specific action items, timelines, and deliverables, providing guidance where appropriate.
- Conduct internal process audits or functional specific audits to ensure compliance with SOPs, regulation, ICH E6 R2.
- Maintain the timeline for any QA specific activities, and deliverables such as clinical investigator site audits.
- Attend study specific team meetings and vendor meetings as needed.
QMS Support Procedural Development
- Lead the management of the Standard Operating Procedure (SOP) and Work Instruction (WI) project for all GxP functions (Clinical Operations, Pharmacovigilance, Medical Monitoring, Regulatory etc.). This will include the development of supporting documentation such as checklists, forms, and templates as needed.
- Track ongoing SOP/WI project timelines including SOP/WI finalization deadlines and communicate delays to the QA team and stakeholders.
- Schedule cross functional review meetings to discuss and finalize SOPs, WIs and supporting documentation.
- Develop instructor lead training on an as needed basis to support the roll out of new and/or revised SOPs/WIs.
- Track any future optimizations to procedures and processes.
QMS Support Document Management
- Develop the internal framework for archival of GxP procedural documentation and GxP training documentation in the Electronic Document Management System.
- Establish internal guidelines/WIs for the ongoing management of the archival of GxP procedural documentation and GxP training documentation in central document repository.
- Coordinate with other GxP functional areas to create a central document repository index for all applicable GxP documentation.
- Establish and communicate best practices/ tools for GxP document management for cross functional teams.
Vendor Audits and Oversight Support
- In collaboration with the Sr. Manager QMS, support the GxP vendor audit program operations:
- Coordinate the scheduling of vendor audits.
- Coordinate the vendor audit deliverables for review and approval (audit agenda, audit report, audit observation report and responses).
- Manage the archival of vendor audit deliverables once finalized (audit agenda, audit report, audit observation report and responses).
Education / Experience / Skills:
- BS degree, 3-5+ years of experience within biotech, life science industry.
- Proficient in project management skills for timeline and deliverables.
- Self-motivated, great communication skills, detail oriented and problem-solving skills required.
- Experience with writing and reviewing GxP SOPs, WIs and supporting documentation.
- Experience with working with cross functional teams in early-stage clinical development.
- An understanding of the application of GCPs to early development and commercial products including FDA regulations and ICH guidelines a plus.
- Experience as a system administrator with GxP document management systems and QMS a plus.
- Experience with regulatory inspections (FDA, MHRA, EMA etc.) a plus.
- Experience with Microsoft Office, specifically Microsoft Excel.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.