Job Detail

JOB DESCRIPTION

Job Description

We are seeking a hands on, “get it done” Product Quality Manager, External Quality Assurance Drug Delivery Systems who will be accountable for ensuring that all products managed by External Quality Assurance are manufactured, packaged, investigated, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. With a primary focus on the product release, product quality complaints, deviation management and metrics reporting, as applied to the supply of Medical Device and Combination Product components manufactured by external parties.
 

The role will support 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 maintained, 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. 

The incumbent is expected to drive the partnership within internal and cross-functional groups to achieve objectives and align company expectations as necessary to improve relationship performance against metrics and business goals. 

Core elements of the role include:

• Evaluating and releasing products to other sites with the assurance that the goods were produced in conformance to all applicable policies / procedures and compliance with all governing regulations




• Managing routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer




• Boosting routine and complex change requests and promote process modification change controls




• Providing guidance in the preparation of metrics, procedures, and guidelines; provide proactive training and coaching to initiate quality improvements




• Tracking and monitoring operational and quality performance of the external manufacturer and work with supplier to develop corrective action and preventative action plans as needed




• Gathering, interpreting and reporting in a timely manner data for internal Annual Product Review




• Participating with 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

Education and Qualifications:

• Quality Assurance professional with at a minimum a bachelor’s in biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)




• Previous expertise within the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control




• Working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with expertise in quality, manufacturing, process validation and/or process technology transfer processes




• Excellent technical, organizational, interactive, stakeholder management, and verbal/written communication skills




• Expertise with Quality functions boosting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record / documentation reviews, investigations, corrective actions, complaints, quality system management, etc




• Ability to make assessment of technical reports (example: investigations, product release) and establish acceptability based on organizational needs




• Ability to handle multiple priorities at a time and immediately address urgent issues




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




• Works freely, receives minimal guidance




• Expertise with administration and data entry of technical reports into internal databases




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




• Ability to work across boundaries; demonstrated interactive, relationship building and Leadership skills

#NewCo

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:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R109500