Manager, Document Control, Training

🕒 vor 1 Monat

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

Secura Bio, Inc.

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2019

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

💰 €90.000.000 Debt Financing - Secura Bio im 2019-03

Healthcare • Manufacturing • Biotechnology

Secura Bio, Inc. ist ein biopharmazeutisches Unternehmen im kommerziellen Stadium, das sich auf die Entwicklung, Vermarktung und Optimierung von Krebstherapien konzentriert. Das Unternehmen legt Wert auf kommerzielle Strategien und Marktzugang für Krebsmedikamente, unterstützt durch Fähigkeiten in der klinischen Entwicklung (klinische Studien, erweiterter Zugang, von Forschern gesponserte Studien), medizinische Bildung und Patientenunterstützungsprogramme. Mit Hauptsitz in Berkeley Heights, New Jersey, und einem Büro in Dublin, Irland, positioniert sich Secura Bio, um die kommerziellen Ergebnisse für Krebstherapien wie Duvelisib zu maximieren.

Beschreibung

• Manage and oversee day-to-day operations and lead continuous improvement efforts in the Quality Management System (QMS), including Document Change Control, Document Control, and Training, to support GxP compliance across multiple areas. • Responsible for supporting and overseeing Document Control activities for documents used in GxP operations (includes manufacturing, clinical, regulatory, and product quality related documents) and archiving activities. • Facilitates and supports the creation, revision, and obsolescence of GxP controlled documents, to include reporting, periodic review, and trend analysis. • ACE administration: management of the eDMS (document change requests, training) and records management. • System administration activities such as creating, monitoring and maintaining Users, Groups and Roles, and Entities (e.g., workflows) within the ACE system. • Record Archival in Ace: Ensuring GxP records are stored in the ACE system. Utilizing the appropriate ACE workflow to store documents. • Support onboarding of new employees in Quality Management System. • Update document control procedures to ensure compliance with GDP (Good Documentation Practices) and relevant GxP regulations and standards for document review, approval, release, retrieval, storage, and retention. • Collaborates with multidisciplinary teams to assist standardize activities within and across quality systems by preparing SOPs and quality processes. • Measure and analyze metrics on change requests and quality records. • Provides input and assistance towards inspection readiness activities. • Assist in investigating and completing actions related to the audit findings. • Act as the subject matter expert for document change control system and training program for Secura Bio, Inc. and during internal and external audits. • Broad understanding of the processes, procedures, and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function. • May assist in Vendor management activities and Quality Management Review (QMR) • Other duties as assigned.

🎯 Anforderungen

• 8+ years of relevant and progressive experience with implementation and management of QA Quality Systems, QA Documentation processes and Good Documentation Practices in the drug, biopharmaceutical, or medical device fields. • Knowledgeable in use of computers and applicable software (MS Windows, MS Office, PDF generation, electronic security implementation, and hosted server applications. • Experience with electronic document control systems compliant to FDA 21 CFR Part 11 • Demonstrated knowledge of FDA regulations and ICH guidance for drugs, biologics and devices as well as international standards for devices. • Knowledge of process design and implementation, change control, auditing, and document management systems. • Demonstrated detail-oriented, strong organizational, management, and communication skills. • Ability to multi-task and prioritize projects to achieve established goals and objectives. • Ability to balance and prioritize multiple projects, duties, and assignments. • Ability to adapt to a fast-paced, team-oriented work environment. • Ability to promote cooperation and teamwork among team members. • Ability to analyze, troubleshoot, and resolve problems/issues as they arise.