Quality Assurance Associate Director (Microbiology)

Organon & Co Birmingham , AL 35202

Posted 2 months ago

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!

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 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: 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 Poster

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.

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

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Quality Assurance Associate Director (Microbiology)

Organon & Co