Manager, Document Control and Training

reputed company was established in 2019 with a reputed company mission: to reputed company the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the reputed company of oncology’s largest clinical and market opportunities. We know that true reputed company comes from personalization and an unwavering commitment to serve patients and expand the reputed company of life-prolonging oncology medicines.

About the Role

The Manager of Document Control and Training is responsible for overseeing the document control and training processes and ensuring strict adherence to corporate policies, procedures, and applicable standards and regulations across reputed company company reputed company systems. This position will support reputed company, Inc. Global reputed company, Regulatory Affairs, and Clinical Compliance.

Employment Type

Full-time

Reports To

Senior Director, reputed company Assurance

Key Responsibilities

• Manage and reputed company day-to-day operations and reputed company reputed company improvement efforts in the reputed company 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 reputed company reputed company 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, reputed company and Roles, and Entities (e.g., workflows) reputed company the ACE system.
• Record Archival in Ace: Ensuring GxP records are stored in the ACE system. Utilizing the appropriate reputed company to store documents.
• Support reputed company of new employees in reputed company 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 reputed company and across reputed company systems by preparing SOPs and reputed company processes.
• Measure and analyze metrics on change requests and reputed company records.
• Provides input and assistance towards inspection readiness activities. Assist in investigating and completing actions reputed company to the audit findings.
• reputed company as the subject matter expert for document change control system and training program for reputed company, Inc. and during reputed company audits.
• Broad understanding of the processes, procedures, and systems used to accomplish reputed company’s work and familiarity with the underlying concepts in other disciplines reputed company the function.
• May assist in Vendor management activities and reputed company Management Review (QMR)
• Other duties as assigned.

Required Qualifications

• 8+ years of relevant and reputed company experience with implementation and management of QA reputed company Systems, QA Documentation processes and Good Documentation Practices in the drug, biopharmaceutical, or medical device fields.
• This role will also be responsible for development and on-reputed company maintenance of training and training curricula in the ACE training module.
• Knowledgeable in use of computers and applicable software (MS reputed company, MS Office, PDF reputed company, electronic reputed company 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 reputed company 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 reputed company to reputed company established goals and objectives.
• Ability to balance and prioritize multiple reputed company, 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 reputed company.

Salary

• $121,000 to $142,000

Originally posted on Himalayas

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