Manager/ Senior Manager Quality Assurance
This Manager/Senior Manager in Quality Assurance will lead the electronic Quality management system (eQMS) and compliance activities for product development and commercialization efforts. This person will work closely with QA Operations and other functional groups to ensure a timely flow of information and requirements including compliance with company standards and GXP procedures. The role is 80%QMS and 20% QA Operations.
Primary Responsibilities
The core function consists of developing, operating and maintaining the EQMS system used to create and maintain controlled documents and training system with Dot Compliance. Support QA operations activities.
- Process, monitor, and maintain all controlled quality system documentation in eQMS system (Dot Compliance)
- Coordinate the approval process, including facilitating and executing of documentation though document change control process.
- Track and manage document control activities, including management of periodic reviews. Provide guidance and training to document owners/authors, collaborators, and approvers throughout the document management lifecycle
- Monitor and drive training compliance
- Develop electronic document control reports in Dot Compliance.
- Manage, support, develop/train QA/DC staff and consultants to support the company's goals and objectives
- Assist in processing requests in a timely and efficient manner.
- Review procedures and other documents to ensure compliance to relevant cGxP requirements
- Create and maintain Document Control System and relevant production documentation
- Filling, scanning, and photocopying as required
- Maintenance and update of all Document Control logs
- Provide relevant training on Dot Compliance procedures
- Maintain technical reports
- Support that the appropriate review and approval of Master Batch Records, Executed Batch Records, SOPs, Change Control Documentation, Product Labeling and Revisions, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, Deviations and CAPAs
- Work with functional areas to determine appropriate training assignments and assign them accordingly
- Support and collaborate with stakeholders for annual review of training assignments and training roles
- Generate and analyze metrics for report out to management and cross-functional areas to ensure routine monitoring of quality system health
- Support maintenance of the eQMS system and learning management system
- Identify and support continuous improvement opportunities within Quality Systems
- Participate on cross-functional teams representing Quality as appropriate
- Support and participate in audits and inspections, and act as subject matter expert for document management and training systems
- Support QA Operations reviews (i.e. Batch Record Reviews)
- Perform internal and external audits as required
- Support Regulatory Inspections
- Perform other QA duties and responsibilities as defined by management.
Requirements
Education and Experience
- Minimum of 5 years of direct experience in document administration in the pharmaceutical or biotech industry
- Minimum of 3 years of Managerial experience
- Expertise in electronic quality management systems (EQMS)
- Requires a minimum BA/BS degree. Science degree preferred
Knowledge, Skills, and Abilities
- Extensive Knowledge of cGMP/GLP regulations highly preferred
- Demonstrated skills in using database management
- Must have Experience with DOT compliance or other EQMS systems
- Strong computer skills
- Excellent Word processing skills
- Experience in Excel, PowerPoint and Outlook required
- Strong technical writing and editing skills
- Superior attention to detail, organization and good grammatical knowledge
- Strong interpersonal and communication skills
- Ability to handle changing priorities in a fast-paced environment
- Must be self-motivated and innovative in addressing routine assignments
- Must be able to work on-site for a minimum of 3 days a week
- Travel 25%
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