Director, R&D Compliance & Standards (GCP Quality)
Company: Horizon Therapeutics
Posted on: May 24, 2023
At Horizon Therapeutics, we define success by the number of
lives touched, lives changed, and lives saved. Our global
biotechnology company is made up of agile, out-of-the-box thinkers
with a focus on delivering breakthrough medicines to those living
with rare, autoimmune, and severe inflammatory diseases. This is
the heart of our global mission. Start a career that enables you to
live up to your potential and help others live up to theirs. Join
us. The exceptional support we provide patients and communities
equally extends to our employees. We offer industry-leading and
award-winning benefits, compensation and rewards programs that
positively impact all areas of our employees' personal and
professional lives. Position SummaryThe Director of RDCS is
responsible for delivering all aspects of R&D Compliance &
Standards. This is focused on compliance and standards across
R&D to be compliant with Horizon process and regulatory
- Provide leadership, mentorship and motivation to a complex,
distributed, group delivering upon critical business needs.
- Effectively prioritize and plan work deliverables across the
groups, managing competing needs and uncertainties. Align
departmental work with larger R&D goals.
- Communicate effectively internally across Horizon the roles and
deliverables of the RDCS to ensure delivery and collaboration is
- Identify and resolve areas of cross over, or handoff, with
other Horizon functions that impact RDCS & Core Function
- Continually assess operating model for opportunities for
innovation and simplification, expert knowledge of external
regulatory requirements to determine changes in practices and
standards within Horizon.
- Implement an audit plan per study that supports clinical team
in delivery of well controlled trials. Lead site and vendor audit
planning, collaborate, communicate and delivery with clinical
- Escalate and resolve issues in a manner consistent with Horizon
- Inspection readiness and inspection conduct leadership through
the team. Train, lead, collaborate and plan across R&D for
successful inspection preparation and conduct.
- Develop, communicate and conduct inspection readiness plan per
development asset, prioritized to risk and business need.
- Develop risk assessment tool to support teams focused on
inspection preparation using study performance metrics to identify
and prioritize site risk and inspection likelihood.
- Deliver through the R&D Compliance team the organizational
compliance needs for R&Dcompliance metrics and trending,
presented through compliance dashboardsstudy risk assessment and
CAPA implementationSOP renewal and mappingDeviation identification
and tracking per Horizon QMS needsProvide compliance feedback into
study protocols, ICFs, IBs and CSRsPSMF review and approvalSupport
teams with unblinding needs and process
- Ensure compliance with Good Clinical Practices (GCP), Good
Pharmacovigilance Practices (GVP), standards and all applicable
regulations and guidelines.Qualifications and Skills Required
- Bachelors of Science required. Advanced degree (PhD or PharmD)
- Minimum of (12+) years of clinical research experience
specialty areas clinical research within biotechnology,
biopharmaceutical, and/or pharmaceutical companies within a similar
role, including monitoring and management of clinical studies with
appropriate knowledge of regulations.
- Ability to travel independently up to 20% over the course of a
- Excellent working knowledge of FDA regulations and
expectations, Good Clinical Practice, ICH guidelines, and clinical
- Demonstrated effective personnel and project leadership
- Domestic and international clinical trial experience.
- Excellent interpersonal skills.
- Excellent knowledge of GCP compliance issues.
- Proficient in Microsoft Office.
- Professional, proactive demeanor.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
- #LI-REMOTE Our Values
- Transparency: We value collaboration. Trusting teach other and
tackling tough challenges can make a powerful difference.
- Accountability: We do what's right for our patient communities
through quality decisions and owning our successes and
- Growth: We fiercely innovate and evolve to better ourselves,
our communities and our patients.These three values come to life
through our five Leadership Expectations that apply to all Horizon
- Enterprise Mindset: Look beyond one's team, brand or function
to see the broader company and external perspective
- Exhibit Intellectual Curiosity: Seek to understand what you do
not know; ask the right questions of the right people and
- Ensure Accountability and Courage: Step up to address difficult
issues and hold self and others accountable to commitments
- Embrace Diverse Perspectives: Welcome others with a respectful
attitude; integrate diverse perspectives into ways of working
- Develop Talent: Provide feedback, coaching and mentorship to
help others be more effective in their roleCompensation and
Benefits Summary:The salary range for this role is
$193,500.00-$236,500.00 annually. The base salary offered may vary
based on the final candidate's qualifications. The level of this
role may also change based on the final candidate's
qualifications.In addition to the salary, this position is eligible
for the benefits listed here and for the following plans:Salary
Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity
Grant, Corporate BonusAt Horizon, we know that disease does not
discriminate. We embrace the bold ideas of one another, foster a
sense of belonging, and value inclusion. We attract and develop
diverse talent because we believe that when people from different
backgrounds and life experiences come together, we make lives
better. Horizon intends that all qualified applications are given
equal opportunity, and that selection decisions be based on
job-related factors. We do not discriminate based on race, color,
religion, gender, sexual orientation, national origin, age,
disability, veteran status, or any other characteristics protected
Keywords: Horizon Therapeutics, Naperville , Director, R&D Compliance & Standards (GCP Quality), Executive , Palatine, Illinois
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