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21 days old

Supply Chain Quality Program Manager

Kelly Services
Cambridge, MA 02238
Kelly Services is seeking an **Supply Chain Quality Program Manager** for our well-known client in the **Pharmaceutical industry** in **Cambridge MA.** The ideal candidate will have a B.S. in Engineering, Technology or Science field with at least 5 years of experience in bio- pharmaceutical manufacturing **. This is a 12-month contract role with a possibility of extension.**



**Title: Supply Chain Quality Program Manager**



**Location: Cambridge MA**



**Duration: 12 months**



**Job Description**



**Purpose:**



**Key Responsibilities** :



**ESSENTIAL FUNCTIONS** :






+ Support implementation of vaccine manufacturing and quality systems in collaboration with quality, supply chain and information technology staff. These systems include the Quality Management System and systems required for material control and supply planning.

+ Provide technical support for raw materials and components (RMC) drug product management. Includes writing or contributing to technical assessments in support of RMC deviation management, change control, comparability assessments, and regulatory submissions.

+ Provide life cycle support and continuous improvement of Takedas vaccine manufacturing and quality systems. Identifying and implementing continuous improvement opportunities in vaccine operations use and management of RMC.





**ACCOUNTABILITIES** :




+ Partner with quality, supply chain, procurement, information technology, operations and product development groups to coordinate timely closure of change controls, deviations and CAPAS related to the external manufacturing.

+ Support regulatory section writing and review.

+ Write technical assessments to support deviations, change control, or comparability assessments. Supports relevant regulatory submission sections for new processes, and/or changes to existing processes for various geographies.

+ Support execution of project plans for diluent contract manufacturers.

+ Coordinate risk assessments for raw material and component usage for all Takeda vaccines. Help to identify risks and develops and implement plans to mitigate key risks.



**EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:**




+ B.S. in Engineering, Technology or Science field with at least 5 years of experience in bio- pharmaceutical manufacturing. A degree in biochemical engineering/ biotechnology or related discipline is highly preferred. Specific experience in manufacturing and quality systems or in raw materials and components management is a plus.

+ Must demonstrate knowledge of cGMPs, with applied knowledge of bio-pharmaceutical manufacturing (e.g. biological drug substance production or formulation, filling, and finishing of parenteral products).

+ Possess demonstrated leadership abilities along with technical writing, problem-solving and project planning skills.

+ The candidate must be self-motivated, able to meet project deadlines and budgets. Teamwork and collaboration skills are integral to the position.

+ Demonstrated ability to manage work in cross functional team setting and lead cross-functional team meetings

+ Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies is a plus.





**Why Kelly?**



As a Kelly employee, youll have access to premier perks, including:




+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Outstanding online employee community Corporate discounts




+ Transportation Spending Accounts

+ Offered and coordinated by Leslie & Associates. These plans are not sponsored by Kelly Services.






**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: 2020-05-04 Expires: 2020-06-04

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Supply Chain Quality Program Manager

Kelly Services
Cambridge, MA 02238

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