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Quality Systems and Compliance Contractor

  • Chemistry
  • Clinical Trials
  • Document Control
  • Drug Safety
  • Life Sciences
  • Metrics
  • Pharmacovigilance
  • SOPS
Description:

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

This position will support Blueprint Medicines' Quality Systems and Compliance Quality Systems & Compliance functions in:

Responsibilities:

  • Management in product complaint handling including but not limited to:
    • Intake of Product Complaints from the Blueprint Medicines secured access mailbox
    • Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & Pharmacovigilance
    • Assist in providing product complaint metrics reports
    • Develop training on product complaint handling
    • Assist with revision of product complaint SOPs/WI
    • Archive product complaints in accordance with Blueprint policies
    • Act as a QS&C document control back-up support
  • Will support regulatory inspection preparation and onsite during inspections as required.
  • This position will be a hybrid role including both remote and onsite days

Skills:

1. Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc. 

2. Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc. 

3. Experience with Veeva QualityDocs and Veeva eQMS a plus

B.S. degree in life sciences, chemistry or engineering or equivalent 

Minimum of 5 years’ experience in Pharmaceutical Quality or Regulatory 

 

Pay Transparency:

The pay range that Magnit reasonably expects to pay for this position: $36.00-$46.00/hour.

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen
  • Preferred years of experience : 1+ Years
  • Travel Required : No travel required
  • Shift timings: Not specified
Job Location
Cambridge, Massachusetts
Pay
USD 36.00 - USD 46.00 Per Hour
CONTRACT DURATION
5 month(s)
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Posted: on Sep 04, 2024