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25 days old

Quality Manager

Kelly Services
Frederick, MD 21705
**Job Details:**



**Industry:** Biopharmaceutical



**Work Location:** Frederick, MD



**Job Title:** Quality Manager



**Duration:** 12-18 Months (Temporary/Contract) Possible extension




**_Quality Manager Frederick, MD_**



Kelly Services is currently seeking a **Quality Manager** for one of our top clients in **Frederick, MD** .





**JOB DESCRIPTION:**



**Ideal Candidate Profile:**

-Experience with stability program management of biologics products

-Experience with license management

-Experience with continuous improvement processes

-Experience with LIMS is a big plus


**Job Description:**

The Quality Manager is responsible for quality assurance, in relation to all aspects of global commercial stability management and will evaluate stability information to support license management. The job holder has responsibility for commercial product portfolio and ensures compliance of this with commercial stability obligations. The job holder communicates with stakeholders and project team members, advising and influencing them in the area of product stability.


**Job Responsibilities:**

Responsible for ensuring compliance with commercial stability obligations through designing, implementation and maintenance of the Stability Program for biologics products. The core responsibilities include:

Generation and maintenance of the Stability Program for assigned products (drive stability study designs, author protocols, GQCLIMS Stability Static Data-load in collaboration with key stakeholders

Plans, designs, and executes multiple simultaneous projects that are complex and technically demanding through significant interactions with internal and external cross functional stakeholders.

Acts as a subject matter expert for stability program of assigned products. Drives the implementation of post marketing changes (new container closure systems etc) into stability program.

Supports technology transfers by coordinating with sending units to ensure seamless transfer of stability programs.

Ensures that assigned biologics stability program fulfils all regulatory requirements, and is optimized and effective.

Supports all stability data communication to customers

Supports regulatory submissions (author/co-author relevant regulatory filing sections).

Technical support related to Stability (Product Complaint, Deviations, Change Controls).

Supports regulatory agency inspections for stability-related questions.

Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.

Seek opportunities for continuous improvement, across all aspects of global stability management

To seek opportunities for continuous improvement across all aspects of Global Stability Management


The role demands thorough understanding of pharmaceutical stability testing and a full overview of Operations activities and how this contributes to achieving the objectives of the business.


**Essential Qualifications:**

Strong communication skills (listening, verbal and written in English)

Excellent team working skills.

Accurate and thorough information handling.

Able to analyze qualitative and quantitative stability information in order to draw conclusions and make recommendations.

Recognizes different perspectives and is able to communicate with others to influence positive outcomes.


**Desirable Qualifications:**

Educated to degree level in pharmaceutical, analytical or related subject

Experience in a quality function

Experience in analytical or pharmaceutical sciences

Experience in LIMS builds end admin support.



**Why Kelly?**

As a Kelly Services employee, you will have access to numerous perks, including:




+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*



**Apply Today!**




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-09-28 Expires: 2020-10-29

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Quality Manager

Kelly Services
Frederick, MD 21705

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