Job Detail

JOB DESCRIPTION

Job Description

An exciting role is now available for a Senior External Quality Specialist who will be accountable for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.

This role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners EP/ExP’s manufacture and release of (API intermediates, API, non‐sterile pharmaceuticals, sterile pharmaceuticals, medical devices) by means of risk‐based quality oversight and on‐site supervision, as appropriate.

In the role of Product Quality Manager (PQM), the EQA senior specialist will assist partner relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of partners supported production volumes, number and complexity of markets, historical performance (production and compliance), new product or market launches, historical relationship between with the partner, manufacturing process complexity.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records


• Manage routine and complex deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer


• Provide assistance for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented


• Oversee repackaging activities in the External Party


• Conduct routine and solves complex analytical change requests and assist process modification change controls.


• Stability Program management, including review of stability reports, and Annual Product Review assembly


• Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements


• Track and monitor operational and quality performance of the external manufacturer/partner and work with supplier to develop CAPA plans


• Assist the maintenance of retention samples, ship reagents and samples to assist licensure and foreign registration; responsible for shipment under quarantine


• Assistin routine process validation; review and approve validation reports/tech transfer


• Prepare pre-PAI assessments; assist document requests for regulatory filings and post approval changes


• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).


• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred


• Solves complex problems; takes a new perspective using existing solutions


• Works independently, receives minimal guidance


• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME


• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others


• Explains difficult issues and works to build alignment around a complex situation


• Accountable for a medium sized project with minimal resource


• requirements, risk and/or complexity


• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills


• Communicates easily in English both verbally and in writing


• Strong knowledge of External Manufacturing management, supply chain, and operations


• Lean Six Sigma Systems training an advantage

Merck Sharp & Dohme Corp.,(headquartered in Kenilworth, NJ, USA) has made the decision to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses to form a new, independent company. This new company, named “Organon”, will become an independent, publicly traded company in 2021 with its global and US headquarters to be based in Jersey City, New Jersey, USA.  We expect that additional Organon sites will be in the general vicinity of current Merck Sharp & Dohme Corp locations.

For this exciting new opportunity, we  are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership.  Working together, we will make a significant impact on the health and lives of people around the world.  

For more information about Organon, please click here. 

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R105170