Quality Assurance Associate Director (Microbiology)
Company: Organon & Co.
Location: Sarasota
Posted on: June 25, 2022
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Job Description:
**Job Description**Organon is a Womens 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 womens 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.Were 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, youll 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.Its going to be an exciting futurecome 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
to):**+ Identifying the compendial, regulatory requirements and
cGMP expectations; developing implementation plans for the Organon
Network+ 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 and variances).+ 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 practice.+ 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 prioritized topics.+ 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.**Skills**
**:**+ 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 objectives+ Experience in
coordinating large, complex cross functional projects with tight
timelines Strong communication skills, written and oral+ 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 structure+ Knowledge of GMPs;
Pharmaceutical experience preferred+ Microbiology and Manufacturing
related compendial and Regulation knowledge preferred**Required
Education** :+ 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 Womens 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 roles pay
range: email: coloradopayact@organon.com**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
staffingaadar@organon.com .For more information about personal
rights under Equal Employment Opportunity, visit:EEOC PosterEEOC
GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency
RuleOrganon 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.**Employee
Status:**Regular**Relocation:**No relocation**VISA
Sponsorship:****Travel Requirements:**25%**Flexible Work
Arrangements:**Remote Work**Shift:****Valid Driving
License:****Hazardous Material(s):****Number of
Openings:**1**Requisition ID:** R509217
Keywords: Organon & Co., Sarasota , Quality Assurance Associate Director (Microbiology), Executive , Sarasota, Florida
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