Manager, Quality Management Documentation
Multiple Locations: Austin, Texas, United States • United States
Requisition Number: 4909
Position Title: Manager, Quality Management Documentation
SUMMARY: The Manager of Document Control is an experienced GxP workflow and process design expert who works collaboratively across Worldwide to design and produce clear, concise and effective Quality Documents and drive efficiency and effectiveness improvements in Worldwide’s document management process.
The Manager of Document Control fosters a culture of continuous improvement, participating in cross-functional initiatives and collaborating across the organization. This individual Quality Management Document (QMD) process owners, subject matter experts and collaborative reviewers (subject matter experts) to guide the design of workflows and processes and write clear, QMDs (standard operating procedures, work instructions, templates and forms) related GxP documents in support of the Quality Management System.
- Identify areas for improvement within the QMS and QMD processes and collaborates on solution-focused activities to implement improvements
- Thinks creatively and participates in development and implementation of strategies to engage employees and ensure visibility, access and clarity of quality procedures
- Champions change management across the organization, especially as related to QMDs and QMD-related processes and technology
- Initiates the QMD collaborative review process, identifying opportunities and solutions to improve efficiency and effectiveness
Design, Writing, and Editing
- Works collaboratively with process owners to design workflows and assist them in writing clear, concise QMDs and related GxP documents to support the Quality Management System and Quality Manual
- May perform initial QMD collaborative review as a Quality Assurance representative; cross trains to perform formal QMD quality control activities and assists when QC workload is high
- Mentors process owners to collect input from stakeholders and manage the response and consensus processes through finalization
- Creates or assists with creating process maps and other process representations and assists process owners in transforming them to QMDs or supporting materials.
- Works with functional area SMEs to develop cross-functional process models
- Creates and delivers training for process owners, subject matter experts and collaborative reviewers on process mapping, workflow design and procedure writing and content review
- In collaboration with corporate training function, assists in training functional training coordinators on considerations related to QMD assignments
- In collaboration with corporate training function, designs training and communications related to specific content of QA QMDs and in development of QMD training effective measures
- Contributes to design and delivery of new employee QA orientation and quality system refresher training
- Fosters compliance with corporate and industry QMD standards, including formatting requirements, content quality and organization, and regulatory-forward awareness
- Contribute to the development and maintenance of up-to-date SOP writing procedures so that the process is followed and consistently applied by all process writers and authors
- Collaborates with cross functional partners to identify gaps in current procedures and systems and leading effort to gain remediation, including ensuring current US and international regulations, laws, and guidelines are reflected in QMDs.
- Contribute to solutions to improve visibility, communication, and navigation of procedures across Worldwide.
- Solicits feedback from stakeholders to ensure Document Control procedures are meeting the needs of the business and initiates and implements improvements
- Create communication across the organization to ensure all areas are sufficiently informed of QMD releases, changes and requirements.
Contribute as a Document Control team member
- Follows departmental processes and standards to ensure consistency and compliance within existing tools and trackers
- Reviews QMD-related noncompliances and manages initiatives to improve compliance by enhancing clarity
- Work collaboratively and proactively as a team member and supports team members to achieve overall objectives.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Hands-on experience writing quality management documents, designing process workflows and accompanying job aids in collaboration with subject matter experts
- Experience leading complex cross-functional projects, identifying process connections and gaps
- Strong teamwork orientation essential
- Experience with electronic Document Management Systems (eDMS) preferred
- Experience developing and tracking key quality metrics to identify areas for improvement
- Demonstrated success managing quality system elements, such as noncompliance management and document change control
- High degree of initiative, decision making skills and responsibility, enabling the incumbent to perform effectively with minimal supervision
- Ability to effectively prioritize and manage multiple projects and tasks and to assist subject matter experts in meeting timelines
- Experience designing and delivering training content related to GxP and process mapping and writing
- Builds productive working relationships across the organization by listening effectively and inviting discussion
- Communicates in an open, clear, complete, timely and consistent manner and express ideas in written and oral context
- Exhibits a flexible, regulatory-focused approach to problem solving and applies risk-based decisions
- Is an adept negotiator, assisting process owners to reach cross-functional consensus on content
- Handles multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
- Experience working remotely via video technology preferred
- Four-year university curriculum, preferably in life sciences
- Additional formal training in process mapping and technical writing strongly preferred
- A minimum of 10 years of Quality Assurance GxP experience in biotech or pharmaceutical environment or other regulated industry
- Exceptional level of written and oral fluency in the English language; attention to detail and nuance strongly preferred
- Strong understanding of domestic and international GxP regulatory requirements
- Experience with audits and regulatory authority inspections
- Experience with development and implementation of quality systems
- Domestic and international travel required (approximately 15%)
Employment Type: Regular
Community / Marketing Title: Manager, Quality Management Documentation
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.