As an integral member of the Enterprise Quality Assurance management team the Lead Quality Systems Administrator oversees the development, implementation and maintenance of the Enterprise quality system at the assigned divisions, with the guidance and support from the Quality Assurance Directors and VPs. The QA Manager provides day-to-day direction, support and leadership to the QA associates and ensures that the team has adequate resources to meet its responsibilities. Additionally, this role provides QA input and advice to the management teams of the assigned business units (i.e., programs and/or departments) and assures the business units remain compliant with established procedures, client contractual agreements, EQA policies and procedures, and applicable regulations and guidelines by scheduling routine program/department audits and process/system audits to ensure client contractual agreements and EQA standards are met. This position is expected to interact directly with clients/sponsors, vendors and regulatory inspectors. The Lead Quality Systems Administrator should be highly proficient in eQMS technical configuration, understanding development processes, and maintaining infrastructure hygiene (i.e. ensuring eQMS subscription has adequate storage space and projecting future needs). The Lead Admin will also be responsible for managing up to 3 additional administrators with varying levels of experience, monitoring their performance, and ensuring completion of assigned administration duties. Where junior resources are added to the team, the Lead Admin is expected to provide education, training, and guidance in developing their skillset. Will act as the final level of escalation for complex technical issues impacting service availability. Work with project managers to coordinate and plan project tasks and resources. Lead Administrator, QMS should be highly proficient in eQMS technical configuration, understanding development processes, and maintaining infrastructure hygiene.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Oversee Quality Systems administration team, ensuring timely completion of assigned duties
- Manage queue of requests from eQMS userbase through ServiceNow ticketing, tracking metrics, and reporting on overall current state of eQMS development
- Creation of presentation materials, demonstrating timelines for assigned projects, milestones, and delivery of value
- Host and coordinate external audits by sponsors/clients and/or regulatory agencies.
- Coordinate collation of responses and corrective actions from external audits with relevant program and/or departments to ensure timely resolution of observations and issuance of responses.
- Leverage QMS Engineering experience to drive development around best practices and optimal system performance.
- Works closely with IT / QA to manage risk, verification, quality, and validation plans.
- Maintain accurate records of internal and external audit files, including schedules, audit plans, audit evidence and audit reports. Assist in the archiving of QA documents.
- Implement Quality Assurance procedures as per internal requirements and/or client contractual requirements;
- Organize, schedule and conduct internal audits for the various programs and/or departments (as assigned by the Director, QA) to ensure client requirements (e.g., procedural steps, operational reports and AE reporting, etc.) are met and company policies and procedures are complied with;
- Ensure program/department audits and internal process/system audits are scheduled in advance and reflected in the QA audit calendar;
- Analyze and evaluate available data and prepare or review written reports of audit findings and observations;
- Keep QA management up to date on findings and status of corrective/preventive actions;
- Manage the CAPA process for the assigned programs/departments by ensuring that non-conformance and other reportable events as well as CAPA reports are recorded, followed-up, tracked and trended;
- Conducts periodic Quality Management Review (QMR) meetings with Patient Support Program Management Teams and related functional areas to review key quality metrics, discuss trends/issues and coordinate quality improvement initiatives.
- Implement continual process improvements related to assigned program/departmental processes and/or internal processes as required;
- Manage the controlled documents (Policies, SOPs, WIs and Forms) request, review and issuance work flow by actively liaising with each program/department management as assigned, and coordinating with the respective programs/department managers or designates to ensure the controlled documents are generated and finalized in a timely manner;
- Understand program/project roadmap and key milestones regarding criticality, downstream impact if dates are missed and determine alternative/mitigating actions.
- Provide timely, concise communications to functional and executive leadership regarding project status and pending issues.
- Build consensus among multiple functional and technical leads relative to project audit scope, task execution, staffing and issue resolution.
- Recommend corrective actions to program/department leadership when project deliverables deviate from the work plan with the assistance of team members.
- Interact with project sponsors, stakeholders, vendors and various project members to ensure that specified business needs are met; assists in the post-implementation analysis to ensure that requirements are fulfilled.
- Serve as a resource to internal stakeholders for the interpretation and application of regulations and applicable guidelines;
- In coordination with the Director, Quality Assurance, prepare QA budget and manage departmental expenses;
- Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required;
- Understand and apply company Confidentiality and Privacy Agreements
- The Quality Assurance Manager may also be assigned other duties and tasks as required from time to time by the Director, Quality Assurance.
- Travels up to 20% of the time.
What your background should look like
- Bachelor of Science Degree in a scientific, healthcare or pharmaceutical field, or equivalent.
- Minimum of 5 7 years experience in the healthcare, pharmaceutical or biotechnology industry (or similar), preferably in a quality assurance or quality control function.
- Minimum of 5 years experience in hosting external audits and management of multiple projects (planning, implementation, management and monitoring) including budget, resource planning, Key Performance Indicators, etc.;
- Industry certification in Quality or Clinical Research (e.g., CQA, RQAP-GxP, CCRC, CCRA, CCRP, etc.) is an asset.
- Responsible and accountable for success/delivery of quality needs for QMS system
- Responsible for managing 1-3 QMS engineer resources in delivery of high-quality business/customer service and consultancy to QA departments
- Experience coaching junior/entry-level resources, ability to create development plans, and foster growth and QA knowledge in reports
- Experience in executive reporting and developing product roadmaps to communicate QMS growth strategy
- Quality or quality parallel professionals with 5-7 years experience, with extensive experience in a QMS System (i.e. MasterControl, TrackWise, Veeva)
- Extensive knowledge of GxP, GDP, GMP, ISO 9001 and related Quality Standards
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- Strong knowledge in quality assurance principles and quality management, including design and operation of effective quality and regulatory compliance programs;
- Advanced knowledge of root cause analysis and CAPA investigations;
- Ability to develop and implement customized Quality Assurance procedures specified by internal/external industry specification;
- Advanced analytical, conceptual and problem solving skills to evaluate business; problems and apply knowledge to identify appropriate solutions;
- Well-developed leadership, analytical, and decision making skills, with an aptitude to appropriately apply scientific, regulatory and administrative knowledge to accomplish department and company goals.
- Superior skills in planning, organization and managing multiple priorities yet being flexible, adaptable and able to respond to changing needs.
- Proven conflict management skills with the ability to provide leadership to others in response to situations and to escalate more critical decisions when relevant.
- Excellent verbal and written communication skills, work well in an interdependent team environment, and promote positive, respectful professional relationships. Proficient in writing reports containing technical information;
- Effective presentation skills and experienced in the development of training courses and materials.
- Proven ability to organize time, set priorities and multi-task in order to meet various competing work deadlines;
- Strong attention to details and data analysis skills;
- Ability to work independently and in a team environment;
- Strong proficiency in Microsoft applications (Word, Excel, PowerPoint, , Outlook), Adobe Acrobat.
Originally posted on Himalayas