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Rippling
3.7
Manager, Document Control and Training
United States
$121K - $142K (Employer provided)
Knowledge of process design and implementation, change control, auditing, and document management systems. Responsible for supporting and overseeing Document……
26d
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Rippling

3.7

Manager, Document Control and Training

United States

$121K - $142K (Employer provided)

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Use AI to find out how well the skills on your resume fit this job description.

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

See company reviews

Base pay range

The minimum salary is $121K and the max salary is $142K.

$121K – $142K/yr (Employer provided)

$132K

/yr Median

United States

If an employer includes a salary or salary range on their job, we display it as "Employer Provided". If a job has no salary data, Glassdoor displays a "Glassdoor Estimate" if available. To learn more about "Glassdoor Estimates," see our FAQ page.

Working here doesn’t have to be a secret

3.7

Recommend to a friend
Approve of CEO
CEO: Parker Conrad
800 Ratings

Rippling

3.7

Manager, Document Control and Training

United States

$121K - $142K (Employer provided)

Rippling

3.7

Manager, Document Control and Training

United States

$121K - $142K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

About the Role

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

See company reviews

Base pay range

The minimum salary is $121K and the max salary is $142K.

$121K – $142K/yr (Employer provided)

$132K

/yr Median

United States

Working here doesn’t have to be a secret

3.7

Recommend to a friend
Approve of CEO
CEO: Parker Conrad
800 Ratings

974,936 Standards and practices jobs in United States

Base pay range

Working here doesn’t have to be a secret

Base pay range

Working here doesn’t have to be a secret