Job Description
The Position
Individual contributor is accountable for ensuring that all of Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.
The incumbent may also be accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and Company policies.
Responsibilities:
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations; review and approve changes to master batch records or laboratory methods/specifications.
Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
Accountable for Quality Control functions including 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.
Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.
Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.
Preferred Education, Experience, and Skills:
Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
Minimum of 5 years working experiences in the pharmaceutical industry and quality management and at least 3 years working experiences in sterile manufacturing and quality management.
Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
Communicates in English, both verbally and in writing.
Prior management experience preferred.
Moderate level of contractual and financial awareness.
Previous experience participating in regulatory inspections.
Be conversant with all domestic and foreign regulations and compendia governing plant operations.
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:
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: