Job Description
Responsibilities
- Provide quality oversight support for the supplier management system -ETQ SMC module within the OMS Division, ensuring compliance with company policies, procedures, and regulatory expectations. This includes involvement in all Quality Activities supporting the ETQ SMC platform module for all Supplier related activities in support of GMP processes which are required by our Quality Standard that have potential for impact on product quality, patient safety or data integrity.
- Work closely with stakeholders and SMEs from Internal Manufacturing sites, DIMQ, External Manufacturing, Global Quality, Procurement, and Global Auditing to provide quality oversight throughout Supplier oversight lifecycle inclusive of qualification through ongoing monitoring and disqualification within the ETQ SMC module.
- Support QMS External Network topic lifecycle in regards with ETQ SMC module activities.
- Support creating and updating related procedures, training related documents and quality system management documents.
- Acts as a Business Admin of ETQ-SMC module (Approved Supplier list system): this includes creating, approving and maintaining records in the database, monitoring, investigating and resolving data discrepancies, design platform enhancements as required, and maintaining the database inspection ready.
- Support Business Owner activities for ETQ-SMC module
- Support Power BI dashboard for Supplier related subjects including the design and enhancement of new dashboard in collaboration with stakeholders and functional SMEs.
- Provides support to Organon using sites and functions during regulatory inspections or our Company internal audits, as requested per area of expertise.
- Support generation of periodic metrics for SQM across functional support areas
Required Education, Experience, and Skills
- The expertise required to fulfill this role includes technical database management background and experience, data stewardship expertise (ETQ, QDM, Snowflake). In addition, the OMS ETQ SMC database is a newly designed less than one year ago module and highly configurated.
- Knowledge and Expertise of the legacy ST system is recommended and expertise of ETQ SMC module desired, knowledge of the supply chain management desired.
- At least 3 years of Quality, Operational and technical experience within a Biotechnology, Pharmaceutical, or Device Industry environment.
- Able to prioritize multiple initiatives.
- Demonstrate Collaborative leadership approach Demonstrate good judgment and logic, and influence stakeholder.
- Good problem-solving skills.
- Good written and oral communication ability.
- Communicate and escalate issues as necessary.
- Certificates B.S, in chemistry, chemical engineering, microbiology, biochemistry, biology, biological engineering, or similar scientific discipline OR equivalent combination of education and work experience.
Secondary 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.
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 Range
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
No Travel Required
Flexible Work Arrangements:
Not Specified
Shift:
1st - Day
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1