The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, industry guidelines, and Apnimed policies and procedures for the conduct of clinical studies.
The position will utilize audit and inspection intelligence, SOP development, training and risk mitigation plans to assure adherence to GCP/GPV requirements in conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. The position is accountable for the execution of Quality Assurance (QA) audit activities on assigned studies/products/vendors and preparation of the organization for BIMO inspection. This role is responsible for Good Clinical Practice (GCP) and Pharmacovigilance (GPV) oversight, and for assessing the compliance of studies with Apnimed Standard Operating Procedures, Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, EU Directives, ICH).
KEY RESPONSIBILITES:
Prepare and conduct GCP/GPV compliance audits of investigator sites and vendors.
Generate audit reports and communicate results to relevant internal and external stakeholders.
Interact with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure, as applicable.
Activities may include routine and directed audits of investigator sites, vendors, regulatory documents, marketing applications, third-party collaborations, and due diligence activities.
Actively support the development and deployment of an Apnimed BIMO Inspection Readiness/Management program to support competent authority inspections for sponsor, clinical sites and vendors.
Represent Quality Assurance as subject matter expert (SME) and a single point-of-contact for guidance on clinical studies.
Serve as a member of project teams with participation in the applicable forums, providing GCP compliance advice and guidance to achieve continuous quality improvement and effective quality control.
Interfaces with relevant stakeholders including regulatory affairs, clinical operations, and development sub-teams, as appropriate to provide GCP/GPV and QA expertise.
Contributes to the QA strategy and supports QA goals for the aligned studies in each therapeutic area and/or region.
Proactively identify, analyze, and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments to support the implementation of associated risk mitigation strategies.
In partnership with leadership, actively contributes to quality management oversight activities.
Ensure appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects and/or products.
Interface and provide day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
Participate in the development and enhancement of policies and procedures to ensure compliance with applicable guidance documents.
Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents against ICH guidelines, applicable government agency regulations and guidelines, as well as company policies, procedures, and industry standards.
Function as a strong technical resource when called upon to resolve issues based on knowledge of relevant procedures, GCP and GPV regulations and guidelines as well as local regulations.
Promotes standardization of auditing approach.
Design and actively participate in special assignments on various project teams and work streams as determined by management.
Oversees training of staff involved in GCP activities and provides training and mentorship to less experienced members of QA staff.
QUALIFICATIONS:
BS/BA degree in a related discipline with at least five (5) years of relevant experience in the pharmaceutical industry, including conducting a broad range of GCP related audits.
Broad and in-depth knowledge of the drug development process, GCP/PV guidelines, and applicable regulations.
Experience with Bioresearch Monitoring Program (BIMO) Compliance Programs and inspection readiness is required.
Business Acumen/Mindfulness - Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
Analytical Skills - Uses rigorous logic and methods to solve difficult problems with effective solutions.
Communications - Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
Leadership and Decision Making - Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
Creative Thinking - Strong ability to operationalize ideas proposed; frequently engages innovative ideas or ways of doing things and influences creative thinking.
Teamwork - Strong interactive skills with the ability to work effectively in teams.
Time Management - Ability to multi-task and manage time efficiently and effectively.
Work and function at the highest level in a role that may be largely remote from the company offices.