MANAGER / SENIOR MANAGER, DEVELOPMENT QUALITY ASSURANCESUMMARY:We are seeking a highly motivated and experienced quality professional to join our team as a Manager/Senior Manager, Development Quality Assurance. This position provides quality oversight and support for the management of controlled documents within the Veeva quality management system (QMS), including document quality review and lifecycle activities, to promote compliance with applicable global regulations, guidelines, and Ionis procedures and standards. The Manager/Senior Manager will support Development stakeholders by providing guidance for deviations, corrective and preventive actions (CAPAs), effectiveness checks, and other QMS activities. This role is also responsible for monitoring and reporting monthly Development QMS metrics and preparing QMS metrics for the bi-annual quality management review meeting (QMR). This position will perform document audits (e.g., clinical study reports (CSRs)) and trial master file (TMF) audits. The individual may also support with the planning, preparation, conduct and follow-up of global Health Authority (HA) inspections and perform other Development Quality Assurance responsibilities as assigned.
WORK LOCATION: Remote
RESPONSIBILITIES:Controlled Document and QMS Support:
- Provide quality oversight and support for the creation, revision, review, approval, periodic review, and retirement of Development controlled documents within Veeva Quality, in collaboration with Document Control.
- Perform document quality reviews to promote consistency, clarity, compliance with applicable requirements, and adherence to Ionis controlled documents standards.
- Provide guidance and support to Development stakeholders regarding controlled document requirements, workflows, templates, and lifecycle activities.
- Support the management and continuous improvement of Development QMS processes and associated templates/tools.
- Author/revise Development QA procedures/templates/tools as assigned
- Support Development stakeholders with deviations, CAPAs, effectiveness checks as needed.
QMS Metrics and Quality Management Review (QMR):
- Monitor, analyze, and report Development QMS metrics and trends, including deviations, CAPAs, effectiveness checks, controlled documents, and other applicable quality indicators.
- Prepare periodic QMS reports and metrics, analyses, and supporting materials for biannual QMR meetings, and other meetings as applicable.
- Identify recurring trends, potential systemic risks, and opportunities for process and QMS improvement.
- Partner with Development stakeholders and leadership to support timely and effective resolution of identified quality issues.
Audit Responsibilities:
- Conduct CSR and/or TMF audits and may conduct other GCP-related audits as assigned.
- Review audit reports and related responses, corrective actions, and CAPAs, as applicable.
Health Authority Inspections:
- Support with the planning, preparation, conduct and follow up of global Health Authority inspections as assigned.
Other:
- Remain current on new and revised regulations and other regulatory intelligence and potential impact.
- Use approved company technology, including AI-enabled and digital tools where appropriate, to support responsibilities efficiently, while ensuring that all outputs are critically reviewed, verified, and finalized through appropriate human oversight consistent with regulatory and company requirements.
REQUIREMENTS:- A bachelor's degree with a minimum of 5 years of GCP quality assurance experience or an equivalent combination of education and experience is required. Healthcare or scientific related discipline is preferred.
- Strong working knowledge of the clinical development process, ICH Guidelines, applicable global GCP regulatory requirements and quality management principles. Knowledge of other GxP areas (e.g., GVP) a plus.
- Experience writing and reviewing SOPs that support clinical research is highly desirable.
- Experience conducting or supporting GCP audits, document, and TMF audits.
- Experience with electronic QMS platforms; experience with Veeva Quality is preferred.
- Experience managing controlled document lifestyle activities and performing document quality reviews.
- Demonstrated attention to detail and commitment to high quality deliverables while meeting deadlines and commitments.
- Effective verbal and written communication skills.
- Effective interpersonal skills, with the ability to work collaboratively as a team player while remaining flexible without compromising quality.
- Organizational and time management skills.
- Ability to collaborate effectively with cross-functional teams across geographies to achieve shared objectives while encouraging the same in others. Strong customer service orientation.
- Ability to manage multiple projects in a dynamic environment and meet accelerated timelines.
- Ability to travel as business needs require, including on short notice when needed.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004134
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $77,218 to $130,560
The pay scale for the Manager position is $77,218 to $104,500
The pay scale for the Senior Manager position is $93,805 to $130,560
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
