Headquartered in Carlsbad, California, and with offices in Boston,
Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three
decades discovering medical breakthroughs that have redefined life for people
with serious diseases. We’re pioneers in RNA-targeted medicines, and our
platform continues to revolutionize drug discovery and transform lives for
patients with unmet needs. With multiple marketed medicines and a leading
pipeline in neurology, cardiology and select areas of high patient needs, we
continue to drive innovation in RNA therapies in addition to advancing new
approaches in gene editing to provide greater value to patients and are well
positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and
rewarding environment that fosters innovation and scientific excellence. We know
that our success is a direct result of the exceptional talents and dedication of
our employees.
With an unprecedented opportunity to change the course of human health, we look
to add diverse individuals, skill sets and perspectives to our exceptional team.
We continue to invest time, money and energy into making our onsite, hybrid and
remote work environments a place where solid and lasting relationships are built
and where our culture and employees can thrive.
We’re building on our rich history, and we believe our greatest achievements are
ahead of us. If you’re passionate about the opportunity to have meaningful
impact on patients in need, we invite you to apply and join us. Experience and
contribute to our unique culture while you develop and expand your career!
MANAGER / SENIOR MANAGER, DEVELOPMENT QUALITY ASSURANCE
SUMMARY:
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 [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 Benefits
[https://ionis.com/careers#:~:text=Highly%20competitive%20benefits]
Full Benefits
Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
[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.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO
employers.