Job Description

The Position

The Senior Specialist, Global Complaint Management plays a key role in the execution of Organon’s global product quality complaint process. This position is responsible for processing complaint handling records, ensuring they are accurately documented and advanced to the appropriate sites or functions for investigation. The role also manages day‑to‑day operations of the complaint sample laboratory, including receipt and logging of complaint samples, oversight of sample evaluations, and coordination of shipments to investigation sites to ensure timely and compliant analysis.

In addition, the Senior Specialist is responsible for global complaint and customer feedback trending activities utilizing statistical process controls while ensuring data accuracy and completeness to enable reliable signal detection and quality reporting. The role executes complaint procedures in accordance with global regulatory requirements and collaborates closely with Organon manufacturing sites and functional partners to support consistent, compliant complaint-handling practices. The position contributes to process improvements, helping to strengthen performance, efficiency, and compliance within the global complaint management network.

The role is set to be in our Laboratory located in Spring House Innovation Park (SHIP) site located at 727 Norristown Road; Building 4; Lower Gwynedd, PA 19002, 2 to 3 days a week.

Responsibilities

Compile, analyze, and interpret global complaint data, applying statistical process control (SPC) and other analytical tools to support trending, signal detection, and quality reporting.

Manage day‑to‑day operations of the complaint sample laboratory, including sample receipt, logging, evaluation coordination, and shipment of samples to investigation sites. Site based role three to four days per week.

Process product quality complaint records and advance them to the appropriate sites/functions for investigation.

Ensure accurate and timely entry of complaint data in the electronic complaint system and provide system user support.

Support development and maintenance of SOPs and QMS documents related to complaint handling and system usage.

Prepare complaint data and system information for regulatory inspections.

Partner with IT on complaint system enhancements, issue resolution, and user access, as needed.

Participate in continuous improvement initiatives to strengthen the effectiveness, consistency, and compliance of global complaint‑handling processes.

Required Education, Experience and Skills

BS in Science Field, Engineering Field or a related relevant discipline.

Minimum of three plus years' experience within the pharmaceutical industry. 

Strong statistical expertise and previous quality/compliance experience required. Previous complaint experience preferred. 

Requires established ability to manage time with competing priorities.

Requires ability to identify and implement continuous improvement principles. 

Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements.

Ability to persuade others to solve straightforward problems.

Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a diverse environment. 

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

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R538794