Senior Specialist, Quality Assurance

Job Description The Position Ensure that all products are stored and distributed in accordance with all applicable Organon and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations. Ensure the quality performance of external partner (Distribution Center) through direct oversight, support and technical advice, counselling to the partners' site leadership and providing supervision as appropriate. This includes executing permanent audit readiness, tracking partner Quality metrics, providing coaching and training; Quality Control such as atypical investigations and change control requests. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities. Primary Activities Keeps the Associate Director IMQ Quality (US) informed on the status of operations and when challenges, opportunities and/or issues arise. Prepares / reviews / tracks Deviations and Corrective and Preventative Actions (CAPAs) Supports the evaluation and disposition of products (e.g. temperature excursions, damages) Participates and supports global audits to assess competence, gaps, and reliability of external partner Helps to support quality-relevant projects Ensures quality and accuracy of documentation and record retention Acts as a liaison for contact and communications between the partner and internal personnel Supports the preparation of metrics, procedures and guidelines where warranted. Directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of Organon products in the US market. Participates in Tier/Business Review meetings Reviews and monitors established Quality KPI to ensure that quality and compliance goals are met Maintains local Quality Management System Completes quality relevant training as required for the role Must have the ability to travel up to 10% of their time to the US Distribution Centers Education: Bachelor's degree (minimum) in a scientific or engineering field (preferred) or other related areas of study Required Experience and Skills: Must have at least two year of relevant post-degree work experience in a quality position, manufacturing, laboratory setting or related industry experience , Good oral and written communication skills, Must have knowledge of GDP (Good Distribution Practice) and GMP Good Manufacturing Practice), as they apply to the pharmaceutical industry or a related manufacturing environment, Must demonstrate interpersonal skills including flexibility, partnership and inclusion skills, as well as the ability to problem solve, Broad experience in Quality Assurance, and Quality Control also preferred Secondary Language(s) Job Description 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. 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 . For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law. 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. Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Annualized Salary Range (US) $92,400.00 - $157,100.00 Annualized 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites. 10% Flexible Work Arrangements: Not Specified Shift: Not Indicated Valid Driving License: No Hazardous Material(s): Number of Openings: 1 Requisition ID: R528639

Created: 2024-11-02