Description
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!
Position Overview - Basic Functions & Responsibility
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.
- Ensures 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.
- Manage 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 (eg 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.
- Speak Russian is preferred