What are the responsibilities and job description for the Clinical Quality Manager position at Tekcogno?
Job Title: Manager, QA Document and Learning
Location: Hybrid / needs to be onsite for audits, meetings or classroom training Watertown MA
Visa: Only US Citizen on W2/1099/Own Corp/Own LLC
TOP 3 MUST HAVES:
1 Attention to detail
2 regulatory requirements for training documentation
3 Able to Collaborate with various teams
**Highly preferred Veeva for both training and documentation**
Description of Responsibilities:
This position reports to the Sr. Director, QMS and is responsible for oversight of Forma's Document Control, Training, and related Quality Systems.
Description of Responsibilities:
* Oversight and Execution of Document Management and Learning program, including both operational and maintenance activities.
* Manage VeevaVault QualityDocs and Training modules, ensuring system continues in a validated state. This includes representing Veeva QualityDocs and Training as business owner to trouble-shoot user/application related issues.
* Collaborate and work closely with various functional teams to ensure quality GxP documentation and training/learning standards are implemented and followed, as well as identification of cross-functional Document Management and Learning program needs.
* Provide and execute innovative ideas to compliantly advance document process efficiencies, training effectiveness and sharing of best practices.
* Create and maintain QA documentation and learning materials
* Manage QA Doc Control workflows, including reviewing document content, formatting driving consistent process and ensuring oversight of data accuracy and integrity.
* Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
* Lead and mentor Quality Document Management & Learning staff, as applicable
* Leads and represents Quality with a strong voice and embraces Forma's core principles
* Manage problems of diverse scope using a high degree of personal judgment, and must be able to effectively represent Forma Quality to local, corporate, and regulatory agencies.
* Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
* Serve as DocuSign Administrator
Minimum Education/Skills Required:
* BA or BS degree or equivalent industry experience
* Minimum of 7 years of leading Document Control & Training functions in a regulated industry
* Veeva Quality Suite and Platform experience preferred
* Previous experience executing computer system validation deliverables such as User Requirements Specifications and qualification scripts
* Inspection Readiness experience preferred.
* Excellent verbal, written, and presentation skills with the ability to deal effectively across all functional areas
* Able to provide solution minded approach and flexibility to emerging challenges
Job Types: Full-time, Contract
Pay: $50,678.70 - $110,000.00 per year
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- What's your visa status and current location?
Experience:
- leading Document Control & Training functions: 7 years (Required)
- Veeva Quality Suite and Platform: 2 years (Required)
Work Location: Hybrid remote in Watertown, MA 02472
Salary : $50,679 - $110,000
