Job details
Job type full-time
Full job description
Job description
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated against covid-19, or intend to be fully vaccinated against covid-19 by november 24, 2021, or qualify for a medical or religious accommodation to this vaccination requirementHired candidates who are not fully vaccinated by november 24, 2021 with a vaccine authorized or approved by the food and drug administration (fda), and who have not been approved for a legally-required medical or religious accommodation will no longer meet the requirements for employment, and therefore will be considered to have voluntarily resigned their employment, in accordance with applicable law.
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 healthOur mission is to deliver impactful medicines and solutions for a healthier every dayBut 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!
The remediation director will provide compliance leadership and direction to organon and contract manufacturing operation (cmo) sites that manufacture active pharmaceutical ingredients (api), biologics, and finished productsSupport audits and health authority inspections and ensure any resulting corrective and preventative actions (capa) are effectively implemented.
This can be a remote position
Primary responsibilities:
Serve as a subject matter expert for good manufacturing practices for drug products, active pharmaceutical ingredients, and devices.
Ensure new and developing global standards and procedures impacting organon manufacturing sites are fully compliant with international regulatory expectations.
Trend and analyze inspectional observations received across the network for impact to various above-site teams and impact to the network as a whole.
Trend and analyze inspectional observations and enforcement actions within industry for impact and learning opportunities within the network.
Develop and oversee program to share significant site-level inspectional observations between sites and above-site teams to prevent recurrence.
Support remediation activities and pre-approval inspection readiness activities.
Ensure all audits and health authority inspections are assessed and categorized for analytics and trending purposes.
Support audit program by identifying audit targets and help develop protocols for targeted assessments.
Actively participate in industry organizations such as, pda, pqri, phrma, ispe, etc.
Education minimum requirements:
B.a., b.s., m.a., m.s., and/or ph.dIn chemistry, chemical engineering, microbiology, biochemistry, biology, biological engineering, or similar scientific discipline required.
Required experience and skills:
A minimum of 10 years of quality, operational or technical experience within pharmaceutical industry.
Expert knowledge of good manufacturing practices (gmps) and regulatory requirements and expectations.
Experience and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical manufacturing site.
Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
Strong technical background.
Able to travel up to 30% of the time.
Preferred experience and skills:
> 15 years of experience preferred.
Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other gmp/regulatory role.
Who we are:
Organon delivers ingenious health solutions that enable people to live their best livesWe are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care forWe 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 solutionsOur vision is clear: a better and healthier every day for every woman.
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.
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 opportunitiesAll 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 companyNo 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 placeWhere agency agreements are in place, introductions are position specificPlease, no phone calls or emails.
Employee status:
Regular
Relocation:
No relocation
Visa sponsorship:
No
Travel requirements:
Flexible work arrangements:
Shift:
Valid driving license:
Hazardous material(s):
Number of openings:
1
Requisition id: r503138
