External Quality Assurance, Formulation Associate

2 weeks ago

Plymouth Meeting, United States Organon Full time

**The Position**

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.

**Responsibilities**
- 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.
- Assures 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 and ensures 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.
- Manages workload within team scope.
- Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

**Required Education, Experience and Skills**
- Minimum four-year degree in Science, Engineering or other relevant technical discipline (e.g., 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.

Secondary Language(s) Job Description

**Le Poste**

Le titulaire du poste est responsable de toutes les activités sur le site de l'entité externe (EE) associées à la fabrication des produits de l'entreprise, ce qui comprend la surveillance de la qualité de la fabrication, des tests, de l'emballage, du stockage et de la distribution des produits fabriqués dans une EE et de s'assurer qu'ils ont été produit ou testé selon des processus/méthodes approuvés conformément à toutes les exigences réglementaires applicables, aux dépôts réglementaires et aux politiques de l'entreprise.

Le titulaire du poste s'assure également que des systèmes qualité efficaces et robustes sont suivis pour se conformer aux réglementations, politiques et lignes directrices requises régissant la fabrication externe de matériaux pour l'entreprise (par exemple, petites molécules, protéines thérapeutiques, produits biologiques, vaccins, dispositifs, produits combinés, produits stériles)., excipients, ingrédients pharmaceutiques actifs, intermédiaires, graines et banques de cellules) grâce à une supervis

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