Associate Director, Audit and Inspection
Company: Organon & Co
Posted on: August 3, 2022
Organon is a Women's Health Company that believes in a better and
healthier every day for every woman! We are a passionate, global
community of thousands dedicated to redefining the future of
women's health. Our mission is to deliver impactful medicines and
solutions for a healthier every day. But what really makes it work
at Organon is our people.
We're looking for real, passionate team players, curious
innovators, forward thinkers, empowered by the idea of shaping
their career, and ready to bring their fire to embrace change and
the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open,
agile, collaborative culture of a start-up, and operating at the
scale of a Fortune 500 company with an international footprint that
serves people in more than 140 markets.
It's going to be an exciting future-come be a part of it!
THIS ROLE CAN BE 100% REMOTELY BASED IN THE U.S.
Our Clinical and Pharmacovigilance teams manage studies to provide
the safety and efficacy data required for regulatory approval of
potential new drugs, vaccines and new indications for existing
products. We ensure we conduct high-quality clinical trials by
integrating state-of-the-art technology and applying rigorous
scientific and ethical standards.
Under the leadership and directional guidance of the Director,
Audits & Inspections who drives and supports the development and
implementation of strategies and initiatives to maintain and
advance the Research & Development (R&D) Quality Management
The Associate Director will support activities related to audits
and health authority inspections for the various R&D functions
related GXPs and will partner with cross-functional Leads to ensure
the achievement of quality goals. Assignments are complex and
require detailed understanding of regulations and processes to
minimize and mitigate risks.
- Independently supports departmental operational activities
utilizing advanced competencies, knowledge, and judgment;
proactively identifies and resolves complex issues.
- Facilitate on-site audits and health authority
- Supports the global audit and inspection readiness program and
- Support the Director in establishing and maintain a compliance
governance structure providing metrics review of key quality &
compliance activities and to prioritize and ensure ad hoc
topics/emerging are reviewed and escalated in a timely manner.
- Support the collection of quality and compliance metrics and
quality dashboards intelligence.
- Execute the audit strategy including internal process audits
and audits of external business partners Interface and provides
day-to-day quality and compliance support to the functional areas
Analyze and leverage quality indicators and data to identify
potential trends and risks.
- Support functional areas in assessment of potential root causes
and remediation (corrective and preventative actions) and
- Acts as a strong technical resource and is called upon to
assist in issues based on knowledge of relevant Standard Operating
Procedures and GXP regulations.
- Conducts appropriate work in accordance with applicable and
established Standard Operating Procedures (SOPs), applicable
regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance
Practice, Good Clinical Practice,), safety guidelines and company
policies and procedures.
- Collaborates effectively across areas within R&D and
partnering organizations to achieve quality goals and understanding
of and application of appropriate regulations in partnering areas.
Provides inspection management support as needed.
- May develop, contribute to, or lead educational and training
materials and sessions to further develop competencies or process
understanding across R&D functional areas, where
Education Minimum Requirements:
* BS/BA degree in relevant field (Pharma/Science/Engineering).
Required Experience and Skills:
- Minimum 10 years prior experience in the
Pharmaceutical/Biotechnology industry with a thorough knowledge of
Quality Systems, Quality Assurance and Quality Control including
solid knowledge of global GXP Quality and regulatory
- Advanced ability to work in partnership with others within the
Company and external partners to accomplish quality goals;
possesses advanced leadership skills.
- Advanced communications skills to convey and receive
- Advanced oral and written communications skills.
- Expert level skills in problem solving using creative thinking,
gathers data from appropriate stakeholders and responds to new,
complex or problematic situations to influence organization
- Advanced skills to drive change that enhances processes within
quality or across areas within R&D that improve quality and /or
add value to the business.
- Expert ability to organize work efforts, prioritization of
tasks and utilize appropriate resources to deliver or support work
products in accordance with timelines and appropriate
- Advanced skills to utilize knowledge, networks and data to make
rapid and appropriate decisions and to determine when escalation of
issues is necessary.
- Advanced level of knowledge of regulations and business trends
and applies this knowledge to optimize daily activities and make
appropriate decisions that improves the quality of business and
functional area outputs.
- Advanced knowledge of regulations and regulatory trends to
ensure the functional areas within R&D are compliant with
regulations and appropriate procedures and policies and proactively
manages and mitigates risks to achieve quality outcomes.
- Strong verbal skills and experienced effective writing skills
in the area of investigation and deviation reports which include
root cause analysis, impact assessment, corrective and preventative
- Inspection experience a plus.
Who We Are:
Organon delivers ingenious health solutions that enable people to
live their best lives. We are a $6.5 billion global healthcare
company focused on making a world of difference for women, their
families and the communities they care for. We have an important
portfolio and are growing it by investing in the unmet needs of
Women's Health, expanding access to leading biosimilars and
touching lives with a diverse and trusted portfolio of health
solutions. Our Vision is clear: A better and healthier every day
for every woman.
Subject to applicable law, all prospective US Organon hires will be
required to demonstrate that they have been fully vaccinated
against COVID-19 with a vaccine authorized or approved by the Food
and Drug Administration (FDA), or qualify for a medical or
religious accommodation to this vaccination requirement, as a
precondition of employment.
Residents of Colorado: to request this role's pay range: email:
Jersey City and New York City Positions: to request this role's pay
range and benefits, email: firstname.lastname@example.org
US and PR Residents Only
If you require reasonable accommodation(s) in completing an
application, interviewing, or otherwise participating in the
employee selection process, please email us at
For more information about personal rights under Equal Employment
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an equal opportunity employer,
Minority/Female/Disability/Veteran - proudly embracing diversity in
all of its manifestations.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search
firms for employment opportunities. All CVs / resumes submitted by
search firms to any employee at our company without a valid written
search agreement in place for this position will be deemed the sole
property of our company. No fee will be paid in the event a
candidate is hired by our company as a result of an agency referral
where no pre-existing agreement is in place. Where agency
agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Keywords: Organon & Co, Charleston , Associate Director, Audit and Inspection, Executive , Charleston, West Virginia
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