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 Quality Systems and Compliance (QS&C) groups’ oversight of the Document Management & Control and Training Program Administration. There is significant overlap with the Quality Control (QC) group’s application of Veeva QualityDocs as a repository of Quality Control documentation. In addition, the candidate may contribute to other aspects of the QS&C and QC responsibilities, such as audit management (QS&C) or stability program management (QC).
Primary Responsibilities
QS&C
- Document Management & Control
- System Oversight: Exercise administrative governance over the electronic Document Management System (eDMS) by partnering with Senior Manager-QS&C ensuring all workflows maintain a single source of truth and strict adherence to ALCOA+ data integrity principles in collaboration with Functional Department Head and assigned Document Owner/Author via execution of technical Doc Control audits for the initiation, review, approval, revision, and retirement/obsoletion of GxP-regulated documentation, timely performance of applicable periodic review for applicable effective GxP document.
- Act as Subject Matter Expert (SME) for eDMS architecture, troubleshooting workflow bottlenecks and providing high-level technical support to GxP Document Owner/Author and Reviewers/Approvers ensuring compliance with requirements.
- Working with QS&C team and data owners to upload/process documents via an approved protocol ensuring constant “inspection-readiness”.
- Training Program Administration
- System Oversight: Exercise administrative governance over the electronic Learning Management System (eLMS) by partnering with Senior Manager-QS&C to facilitate administrative strategy of the eLMS, overseeing configuration of learner roles, curricula, training requirements/assignments/details, and training requirement impact assessment to ensure compliance with job-function and role requirements.
- Provide training administration support, review, approval of applicable training related contents in collaboration with Functional Area Head ensuring content and trainee eLMS transactions are processed and completed with requirements.
- Review and design report(s) to monitor and follow up on trainee progress, course and/or training assignments, assessment of training effectiveness, compliance, and identify potential compliance risks before they escalate.
- Conduct regular gap analysis of training program by partnering with Senior Manager-QS&C to implement structural improvements to the training matrix based on regulatory trends and internal audit findings.
- Spearhead ad-hoc quality initiative and provide technical oversight for special projects aimed at maturing quality management system.
- Other responsibilities that may be assigned to provide support within QS&C.
QC
- Contribute to the upload of Quality Control Documentation from SharePoint to Veeva.
- Act as an SME on the QC use of the Veeva System. Specifically with regards to the execution of document change controls.
- Assist with the tracking of on-time delivery of stability data, collate stability data, assist in the trending and reporting of stability data.
- Assist with the Coordination and oversight of test sample shipments around the globe.
Core Competencies (Required Skills)
- Deep understanding of the Document Control/Records Management and Training Administration
- Familiarity with SharePoint
- Familiarity with Good Manufacturing Practice and Good Documentation Practice
Preferred Skills
- Familiarity with QC stability programs
- Experience with Veeva QualityDocs and Veeva Training is a plus.
- Understanding of FDA 21 CFR Part 11 & EudraLex Volume 4/Annex 11
- Understanding of ALCOA+ principles and ability to apply to document lifecycle & training audit trails
- Understanding of Computer Software Assurance or System Validation frameworks for maintaining validated state of eDMS and eLMS, knowledge in GAMP 5 is a plus
- Experience with the MicroSoft Suite of applications
- Proven track record of effective communication.
- Excellent interpersonal skills, organizational skills, written and oral communication skills.
- Energetic, flexible, collaborative and proactive; a colleague who can positively and productively impact initiatives.
Education Requirements
- Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
- Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry, with at least 2 years in a dedicated Document Management/Control and Training Administration leadership role.
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.
Top Skills
Keros Therapeutics Lexington, Massachusetts, USA Office
1050 Waltham St, Suite 302, Lexington, Massachusetts , United States, 02421
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