Organon & Co. Quality Assurance Associate Director (Microbiology) in Morristown, New Jersey
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 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.
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 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.
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Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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Requisition ID: R509217