Secura Bio was established in 2019 with a singular mission: to close 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 impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities 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 all company quality systems. This position will support Secura Bio, Inc. Global Quality, Regulatory Affairs, and Clinical Compliance.
Employment Type
Full-time
Reports To
Senior Director, Quality Assurance
Key Responsibilities
- 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.
Required Qualifications
- 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.
- This role will also be responsible for development and on-going maintenance of training and training curricula in the ACE training module.
- 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.
Salary
- $121,000 to $142,000
Skills Required
- 8+ years implementing and managing QA Quality Systems, QA documentation processes, and Good Documentation Practices in drug, biopharmaceutical, or medical device fields.
- Experience developing and maintaining training and curricula in the ACE training module.
- ACE administration and eDMS management (document change requests, training, records management, workflows, user/group/role administration).
- 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 and international device standards.
- Knowledge of process design and implementation, change control, auditing, and document management systems.
- Proficiency with MS Windows, MS Office, PDF generation, hosted server applications, and electronic security implementation.
- Ability to measure and analyze metrics, perform trend analysis, and support inspection readiness and audit findings.
- Strong attention to detail, organizational, management, and communication skills.
- Ability to multi-task, prioritize projects, adapt in a fast-paced team environment, and promote teamwork.
- Ability to analyze, troubleshoot, and resolve problems related to document control and training systems.
What We Do
Secura Bio was established in 2019 with a singular mission: to close 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 impact of oncology’s largest clinical and market opportunities. We leverage our experience to embrace the challenges of commercializing and developing therapies for the most difficult-to-treat patient populations.
