Manager, Quality Assurance Contractor
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 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).
Requirements
- Deep understanding of the Document Control/Records Management and Training Administration
- Familiarity with SharePoint
- Familiarity with Good Manufacturing Practice and Good Documentation Practice
- 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.
Nice To Haves
- 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.
Responsibilities
- 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”.
- 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.
- 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.
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What This Job Offers
Career Level
Manager
