Senior Specialist, External Quality Assurance (EQA)

Job Description

The position

Essential function(s) includes, but is not limited to:

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.

Additionally, the employee may also have the primary responsibility of Qualified Person according to EU GMP Annex 16 for batch certification and release confirming compliance for manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE

Responsibilities

Primary activities include, but are not limited to:

• 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 where applicable by procedure with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations (if applicable); 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 involved in 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 (if applicable).

• As QP, must certify that the batch complies with the requirements of the Marketing Authorization and with Good Manufacturing practice, assessing any potential impact of any deviation, non conformance, out of specification result or quality complaint associated with the batch. Responsibility includes verification of supply chain and starting materials, ensuring that any batch from third country is full tested in EU (unless MRA applies) and that all regulatory commitments related to the batch are met, including stability data, post approval variation and that the product quality review is available and considered.

• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied External Entity Oversight Level and product segmentation (if applicable).  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 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’ relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. 
• 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. 
• University Degree and/or relevant experience to be placed in an EU QP licensee

Preferred Experience and Skills:

• Previous experience in a site Quality and Qualified Person role/function 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.

At Organon Spain we have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates.

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:

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:

1