Job Information
Organon & Co. Senior Specialist, Healthcare Product Quality in Plymouth Meeting, Pennsylvania
Job Description
The Position
Responsible for executing complaint procedures to assure Product Quality Complaint (PQC)/Adverse Event (AE) management processes are in compliance with global regulatory expectations.
Responsible for global complaint processes, as well as local quality complaint management. This also includes the receipt and handling of PQC/Adverse Event Quality Investigation Report (AEQIR), performing technical evaluations in support of complaint investigations, including destructive and non-destructive sample analysis. This position will act as the lead of the US Complaint Handling Unit/Complaints BSL-2 lab.
Acts as an effective liaison with Organon sites worldwide for complaint-handling activities to assure regulatory compliance is maintained. Provides expertise on processes and systems for complaint-handling on an on-going basis to enhance existing processes and identify and advance performance improvement.
Responsibilities
Performs complaint sample intake processing activities such as: identifies appropriate investigating site, performs visual/physical evaluation, follows up on inconsistencies/escalates issues identified, documents sample information, and prepares sample for shipment to investigating site. Performs non-destructive analysis and/or functional testing, when designated by LCIU, documenting all findings in the complaint records.
Serves as a Global Complaints Subject Matter Expert and team lead for US Complaints Handling Unit/Complaints BSL-2 Lab under the direction of the Associate Director. This includes providing technical knowledge and leadership to maximize in-house sample analysis, scheduling run-the-business work, coordinating investigations, upskilling team members, addressing complaint inquiries, ensuring safety requirements are met, etc.
Performing and coordinating PQC/AE activities, including PQC intake, handling samples, investigations, compilation and analysis of PQC/AE data. Acts as project lead on various projects on both a global and local scale, ensuring effective change management.
Authors, reviews, and/or approves Standard Operating Procedures/other document types to assure consistent processes for end-to-end complaint management.
Participates in regulatory inspections.
Lead/support cross-functional meetings such as monthly Complaints Community of Practice (COP).
Leads or participates in departmental and global teams focused on improving effectiveness of complaint processes. This includes identifying and implementing continuous improvement projects.
Completes ad-hoc requests such as data compilation/presentation and providing feedback regarding questions related to Complaint Management and Quality Management System.
Lead/support product launch activities and other projects related to Complaints Management/Quality Management System.
Author and/or review Health Authority Responses.
Liase with cross-functional teams to identify, escalate, and resolve issues identified.
All other duties as assigned.
Required Education, Experience and Skills
BS in Science Field, Engineering Field or a related relevant discipline
Minimum of 5+ years' experience within the pharmaceutical industry with previous quality / compliance/manufacturing experience. Strong preference for previous complaint experience.
Requires strong leadership and 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.
Requires strong ability to work independently on both run-the-business activities/projects and proactively communicate/escalate critical information to the appropriate stakeholders.
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 staffingaadar@organon.com .
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
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.
Flexible Work Arrangements:
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
Handling Product Quality Complaint Samples/Bloodborne Pathogens
Number of Openings:
1
Requisition ID: R526398