Associate Director, Clinical Quality Assurance

Keros Therapeutics•Lexington, MA

10d

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary: This role is within the quality unit and is primarily focused on providing support for responsibilities within the Clinical Quality Assurance (CQA) group. The position will manage compliance related to Good Laboratory Practices (GLP’s), Good Clinical Practices (GCP's), Non-Clinical/Clinical Safety Programs and other related activities. This position will be responsible for partnering with the internal Non-Clinical and Clinical Operations Organizations to ensure compliance with all aspects of operations and will support GLP/GCP related Quality Assurance functions, including batch disposition, policy/SOP development and data/record review/approval, and archival.

Requirements

Expert background in FDA, GLP, GCP, GMP and related regulatory requirements as applicable.
The incumbent should have knowledge of drug development principles and drug safety testing.
Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
Demonstrated skills in project management and working with vendors and contractors.
Bachelor's Degree (Chemistry, Biological sciences, Engineering or related degree) required, with relevant experience, preferably in an industry setting; advanced degree is a plus.
8-10 years of related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.

Nice To Haves

Knowledge and functional expertise in Research and Development, in vivo preferred
Experience with Veeva QualityDocs and Veeva Training is a plus.
Experience with the MicroSoft Suite of applications
Excellent judgement and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills.
Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
Energetic, flexible, collaborative and proactive; a colleague who can positively and productively impact initiatives.

Responsibilities

Assist in development, implementation, and maintenance of a robust quality management system in support of Non-Clinical/Clinical Quality Assurance function (and for applicable regulated activities) to meet internal company standards, external regulatory, and customer requirements, including but not limited to, the following tasks:
Creation, review and implementation of policies and standard operating procedures (SOPs) relating to Non-Clinical/Clinical Quality Assurance function and the continuous improvement of the Quality Management System.
Oversee internal/external audit plans and related activities. Actively leverage audit outcomes/trends to achieve sustained improvement in GLP/GCP activities.
Manage effective audits and qualifications of Non-Clinical/Clinical vendors (CROs), and ensure documents are tracked and maintained within standards.
Preparation and active participation during regulatory audits and/or inspections.
Drive quality improvements using Quality Events (Deviations, Change controls and Corrective and Preventive Action (CAPA)) activities and processes.
Directly interface with representatives from Non-Clinical/Clinical Development, Data Management, Safety, Clinical Operations and Quality Compliance. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
Implement short-term and long-term strategies, goals, objectives and tactics relating to Non-Clinical/Clinical quality assurance function and the quality management system.
Represent Non-Clinical/Clinical quality assurance function and quality management system and related processes in connection with internal or external audits, inspections and new business development activities. Assist with quality-related information related to, but not limited to, client assessments, RFPs, contracts and other documentation (as needed).
Maintain current knowledge base of regulations, corporate policies and standards to ensure that the Non-Clinical/Clinical quality assurance functions and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
Support strategic planning by timely communicating Non-Clinical/Clinical Quality deliverables, constraints, risks and options, and collaborating with other related functions.
Assist in providing quality oversight to various GxP Chemistry, Manufacturing and Controls (CMC) related activities, such as batch disposition, data/record review/approval, and archival.
Position may require up to 15% travel or occasional local travel.