Job DescriptionThis is a remote role and must be based in Europe.Organon is looking for an individual contributor responsible to implement Quality Operations (Quality Assurance and Quality Control) policy and discharge all QO responsibilities supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of API intermediates and API. These activities include assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and Company policies and may include the release of all manufactured products. The incumbent will exercise a leadership role in monitoring and maintaining the external partner’s compliance with the FDC Act, ICH, Current Good Manufacturing Practices Regulations, and other pertinent legal requirements.The incumbent ensures the quality performance of external partner’s through direct oversight, support and technical advice, counselling to the external partner site senior leadership and providing on-site supervision as appropriate. This includes overseeing activities such as partner selection, GMP Due Diligence, and establishing Quality Agreements. The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the external partner.ResponsibilitiesPossesses a unique combination of analytical and scientific skills in order to effectively manage and control all activities necessary for support of a Quality Operations program for manufacture, testing, packaging, storage, and distribution of API intermediates and API. Receives guidance on policy issues and direction with regard to operations, but functions independently. Activities include:Assures that the Quality Operations department of the EP operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.Assures the development and maintenance of a Quality Agreement with the EP’s. Provides input into the development of contractual agreements with the EP’s.Executes a program of calibrated Quality oversight based on the product type, capabilities, quality and compliance performance of the EP.A principal responsibility in oversight of an EP may involve releasing API intermediates to other sites with the assurance that the goods were produced in conformance to all applicable policies and procedures of our company and compliance with all governing regulations. Before shipment, he/she will assure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions.Has responsibility for Quality assurance and control functions to include direct support to EP’s, coordination and 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.Has responsibility for maintenance and oversight of ongoing supplier performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews.Reviews all audit outcomes pertaining to the EP’s and ensures appropriate and timely corrective actions are identified and implemented.Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums.Provides support to the EP’s to facilitate and validate new product introductions. Provides compliance input and support, as appropriate for implementation of analytical methodology and process development initiatives. In conjunction with other internal departments, ensures that EP’s are inspection ready for all new product introductions or transfers.Provides support and develops presentations for Quality Council meetings. Provides oversight for presentation content and may support issuance of minutes.Assists in the coordination of significant investigations including Fact Findings. Assists in the coordination of product recalls as needed.Operates in a safe and efficient manner and in compliance with the manufacturing division Q.O. Safety and Health Policy.Conducts quality due diligence assessments for pre-approval considerations of new EP’s. Supports the EP in remediation of due diligence and pre-contract audit gaps. Assures the development and maintenance of a Quality Agreement with the EP. Acts as the Quality expert on our company's behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the EP on quality related terms.May act as or support the regulatory compliance liaison on our company’s behalf to interface with regulatory agencies.Closely collaborates with appropriate business and operations areas to achieve manufacturing division and company objectivesRequired Education, Experience and Skills Degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)Prior experience in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality Systems and regulatory requirementsPrior experience in API manufacturing and external manufacturing support will be preferred.Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute product.Broad knowledge of manufacturing operations, External Supplier management, supply chain, QA/QC (including engineering, materials, R&D, production, etc.)Must be conversant with all regulations and compendia governing plant operations. Some level of contractual and financial awareness is required.Competent in analyzing complex product, production and testing issues, and have demonstrated scientific problem solving capabilitiesMust have strong demonstrated communication skills. Must have demonstrated personal networking and relationship building skills.Works independently, with guidance in only the most complex situationsActs as a resource for colleagues across multiple areasSolves complex problems; takes a broad perspective to identify innovative solutionsManages large or multiple small projects with moderate resource requirements, risk and/or complexityAnticipates internal/external business and regulatory/compliance issues; recommends product, process or service improvementsCommunicates easily in English both verbally and in writingAbility to make decisions in an ambiguous environmentLean Six Sigma experience desirable Ability to travel 25% of the time on short noticeSecondary Job DescriptionWho 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.As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 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. Annualized Salary RangeAnnualized Salary Range (Global)Annualized Salary Range (Canada)Please Note: Pay ranges are specific to local market and therefore vary from country to country.Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisitesFlexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings: 1