Associate Director, External Quality

Job Description
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!

Essential function(s) includes, but is not limited to:
The incumbent is accountable for all activities at the External Entity (EE)
site associated with the manufacturing of Company products which includes
quality oversight over manufacturing, testing, packaging, storage, and
distribution of the products manufactured at an EE and to assure they have
been produced or tested following approved processes/ methods in conformance
to all applicable regulatory requirements, regulatory filings and company
policies.
The incumbent also ensures that effective and robust Quality systems are
followed to comply with required regulations, policies and guidelines
governing the External manufacture of materials for the Company (e.g. small
molecules, therapeutic proteins, biologics, vaccines, devices, combination
products, sterile product, excipients, active pharmaceutical ingredients,
intermediates, seeds and cell banks) through direct oversight, support and
technical advice, counseling to site leadership, and on-site supervision. The
AD may serve as a subject matter expert for EQA and Division in specific
Quality systems, technology platforms, regulatory expectations and/or EE
management, and can represent the Company in forums on their area of expertise
(both internal & external).
Primary Activities
Primary activities include, but are not limited to:
* May manage a team of Quality Assurance professions as direct reports. Holds regular ‎1-on-‎1 meetings
and Employee Development Plan discussions.
* Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
* Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget.
* Exhibits our company Leadership Behaviors and provides a leadership example for the team.
* Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
* Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
* Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
* May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans. Coordinates the development, with the EQA Senior staff, of the EQA budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
* Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
* Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
* Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes building effective quality systems at the EE and continuous improvement activities.
* Manages workload within team scope.
* Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.
Amount of Travel Required : Ability to travel up to ‎25%, occasionally on
short notice.

Skills

REQUIRED: Education and Experience:
* Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
* Minimum of ‎10 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
* Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
* Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
* Communicates in English, both verbally and in writing.

Preferred Experience and Skills:
Prior management experience preferred.
Moderate level of contractual and financial awareness.
Previous experience participating in regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia
governing plant operations.
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.

At launch, we will be more than ‎10,000 Founders strong, ready to rise together
as we make a difference in a new way. As Founders, employees will create their
future and will help shape the direction of Organon and its impact on the
world. Our culture reflects our passion for those we champion. At Organon, we
all belong. We embrace diversity and give it a voice.

Our commitment to supporting women is reflected in the make-up of our
leadership team, which is majority female and our diversity of experience is
core to who we are and what we are designed to do.
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.
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:
No
Travel Requirements:
‎25%
Flexible Work Arrangements:
Not Specified
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
Number of Openings:
‎1

Requisition ID: R513113