Quality Assurance Associate Director (Microbiology)
Company: Organon & Co
Posted on: June 25, 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.
Position Overview: Basic Functions & Essential function(s)
includes, but is not limited to:
* The Quality Assurance Associate Director (Microbiology) is
responsible for and supports all Quality and GMP Microbiology
Laboratory compliance activities relating to the manufacture of
pharmaceutical & biologic products, to ensure compliance with all
applicable regulations and specifications
Main Activities: (Primary activities include, but are not limited
* Identifying the compendial, regulatory requirements and cGMP
expectations; developing implementation plans for the Organon
* Developing, authoring, and maintaining the quality standards in
alignment with regulatory requirements and cGMP expectations.
* Deploying and ensuring consistency in sites meeting the Quality
Standards (supporting gap assessments, reviewing remediation plans
* Defining and tracking Quality metrics to transform performance at
Organon network sites, where applicable.
* Providing support to CMC when questions arise from regulators
during review of filings.
* Organizing and facilitating compliance related communities of
* Representing Organon in external forums, conferences, and working
groups such as PDA, BPOG, or USP.
* As a Microbiology QA point of contact for a site microbiology
lab, the AD is responsible for: Understanding the compliance gaps
and quality improvement goals for manufacturing and/or microbiology
topics. Coordinating global microbiology team support for
* Working with the sites and regional Quality organizations to
ensure consistency and alignment on microbiology topics.
* Provides expert support to sites related to regulatory
inspections, development of responses to inspection observations,
significant investigations, and guidance regarding corrective
actions and driving standardization across the Network. Co-ordinate
input into draft policies, procedures and guidelines. Author and/or
review technical reports/position papers.
* At least 10 years of work experience in pharmaceutical and/or
medical device microbiology laboratories required with
sterile/non-sterile pharmaceutical manufacturing preferred.
* Strong compliance mindset
* Excellent communication skills
* Ability to work collaboratively in team settings, across
divisions, and within matrix organizations to achieve
* Experience in coordinating large, complex cross functional
projects with tight timelines Strong communication skills, written
* Strong business acumen and technical skills
* Ability to build strong relationships and get work done through
others that may be in a different organizational reporting
* Knowledge of GMPs; Pharmaceutical experience preferred
* Microbiology and Manufacturing related compendial and Regulation
* Bachelor's Degree (B.S.) in an appropriate scientific or
engineering field of study is required. Preferred fields of study
include Microbiology, Biology, Medical Technology, Pharmacy,
Biochemistry, or Engineering.
* An advanced degree, in addition to the required science or
engineering education, is 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:
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:
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