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Sr. Mgr., Third Party & Commercial Quality

Sunrise Systems, Inc Madison Full-Time
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Sunrise System Inc. is currently looking for Sr. Mgr., Third Party & Commercial Quality in Madison, NJ with one of our top client.

Job Title: Sr. Mgr., Third Party & Commercial Quality

Job Id: 19-10777

Location: Madison, NJ 07940

Duration: 6 months

Position Type: Hourly contract Position (W2 only)

Job Summary

  • Be part of the dynamic Third Party & Commercial Quality (TPCQ) team responsible for a portfolio
    of products that include Natural Health Products, Cosmetics, OTCs and Drugs.
  • Under general direction, manages the evaluation of products supplied to the Company from the
  • Third Parties and assures that the product is manufactured and controlled in accordance with Company standards, registrations and regulations, both domestically and internationally.

Job Qualifications (Minimum Requirements)

  • Education and Experience
  • University Degree in Chemistry, Microbiology, Pharmaceutical Science or related field.
  • Minimum of seven (7) - ten (10) years of progressive management experience; preferably in the pharmaceutical industry and including engagement of outsourced service providers such as manufacturers and packagers.
  • Extensive knowledge of the Regulations/GMP’s and experience with regulatory authorities including at a minimum the FDA.
  • Knowledge of other global regulatory authorities is an asset.
  • The ability to influence vertically and horizontally across the organization is essential.
  • Must be able to travel, including outside of USA.
  • Travel is estimated to be 20%-25%.

 


Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

  • Strong knowledge of drug regulations and guidelines.
  • Knowledge in Canadian, European and other global regulations also an asset.
  • Pharmaceutical processes, principles, practices and their application.
  • Responding to inquiries from management, employees and regulatory agencies.
  • Researching, interpreting and analyzing reports, compliance requirements, regulations, contracts and data.
  • Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures or techniques for resolution
  • Administering, and interpreting contractual agreements.
  • Excellent interpersonal, oral and written communication skills.
  • Demonstrated leadership in managing projects and/or product launches and ability to work independently.
  • Excellent negotiation, problem solving and prioritization skills.
  • Strong time management skills, able to manage multiple projects, duties and assignments.
  • Ability to work in a team, both in person and remotely and across various departments.

Contact

Abdul. A

Direct: (732) 272 0298 | Email: Abdul.A@sunrisesys.com

Or

Michael Peng

Direct: (732) 272 0265 | Michael@sunrisesys.com


Recommended skills

Analysis
Time Management
Leadership
Negotiation
Multitasking
Complex Problem Solving
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Job ID: 19-10777

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Sunrise Systems was founded in 1990 and has since evolved into a leading professional Services and Solutions firm specializing in the areas of Staffing, Information Technology development and IT Consulting services. With over 20 years of industry experience, we at Sunrise Systems pride ourselves on our flexible engagement models, designed to cater to our client's Staffing, Consulting and Technology needs. Over the years, Sunrise has built a strong talent pool with a wide range of experienced IT professionals. With our proven placement strategy, we offer clients unparalleled project management experience, technical expertise and industry-specific acumen, as well as the right professionals to fit any unique company culture.
 
At Sunrise, we have always believed that business should be personal. That’s why we have developed flexible engagement models that allow our clients to set the parameters of their software development projects. We work hard to accommodate tight budget constraints and are mindful of short timelines. Moreover, our customizable products strive to meet the specific needs of our clients, eliminating any notion of a one-size-fits-all software solution. Our client-focused operations are strengthened by our ability to perform services either at the customer site or at one of our technology centers. We leverage our offshore and onshore development capabilities as we strive to meet and exceed customer specific requirements.

No matter the challenge or the industry, Sunrise Systems has the experience, talent, and dedication to provide the right solution for your business.

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