Do you have a pharmaceutical quality background and do you have experience in both working with external parties (CMO's) and people management? Then we might have an interesting international opening. For our company, we are currently recruiting an External Site Quality Lead (Associate Director) .
Purpose of the role 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. It's his/her responsibility to assure the products 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.
What are you going to do? Managing a team of Quality Assurance professionals as direct reports.
Contributing to the development of the External Quality Assurance budget.
Assuring compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
Maintaining and providing 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.
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.
Ensuring 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.
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 EQA Senior staff, the workforce planning and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
What is required for the role? Relevant degree (bachelor or master) in a scientific direction, engineering, biology, microbiology, pharmacy, chemistry, chemical engineering, or another relevant field of study.
Strong pharmaceutical quality background, either quality assurance or quality control (minimum 10 years of experience).
Experience managing external relations (e.g.: CMO's) and people management experience (must).
Ability to manage multiple complex issues/topics and projects in parallel and negotiation skills (must).
Experience with regulatory inspections and intercultural collaboration (preferred).
Communication, coaching, interpersonal, and motivational skills.
Experience working with SAP (preferred).
Good English language skills (speaking and writing) are a must.
Traveling: up to 25%.
What do we have to offer to you? We welcome you to a truly global, dynamic, and challenging environment with great opportunities for personal development. We offer a competitive package of compensation and benefits.
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.
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