Associate Manager/Senior Specialist, Quality Systems & Compliance

Associate Manager/Senior Specialist, Quality Systems & Compliance

Cambridge, MA

Requisition Number: 25-602

 

How will your role help us transform hope into reality?

Support GxP Training and Procedural Document Control as well as coordinate functions of the Quality Systems and Compliance department.

 

What will you do?

1. Manages Global Inspection Logistics inclusive of logistics plans/checklists, resource assignment, ready room inspection tool and supporting on-site and remote inspection operations.
2. Assist in maintaining the quality control (QC) of global inspection deliverables by providing support in document preparation, ensuring accuracy, completeness, and compliance with regulatory standards across international operations within the organization.
3. Support inspection readiness activities by coordinating document preparation and facilitating cross-departmental communication.
4. Intake product complaints from both US and international markets, including reconciliation process and generation of reports as needed.
5. Support Periodic Review of vendor records and eQMS records for completeness and accuracy
6. Provide Quality eDMS/eQMS training.
7. Support gap analysis of governance & procedures documents, facilitating continuous process improvement initiatives within the organization by coordinating reviews, tracking changes, and ensuring alignment with regulatory requirements.
8. Conduct global technical/compliance reviews.
9. Collect and prepare metrics reports on controlled procedural documents and Training systems.
10. Serve as a Procedures Administrator.
11. Serve as QualitySuite administrator in electronic Document Management System (EDMS) and electronic Learning Management System (eLMS).
12. Format and perform quality checks on controlled procedural documents.
13. Support GxP Training Coordinator activities in the implementation of GxP area training curricula, staff assignments, and tracking.
14. Support the onboarding of GxP staff and Onboarding training
15. Assist GxP departments in procedural and training document processing and management.
16. Promote and advance a Quality culture through partnership, communication, and transparency.
17. Support governance & procedure and training-related regulatory agency inspection requests.

 

May telecommute from any home office in the US.

 

What minimum qualifications do we require?

Master’s degree in Regulatory Affairs, Pharmaceutical Science, Biotechnology or a closely related life science field (or foreign equivalent degree), plus 2 years of experience in a quality function in pharmaceutical and/or medical devices.

 

Experience, which may be gained concurrently, must include:

• 1 year of experience in pharma or medical device product complaint and/or adverse event processing providing knowledge of cGMP regulations in pharmaceutical or medical device industry to support CAPA, Deviation, and Change Control
• 2 years of experience working with regulated controlled documents
• 2 years of experience in supporting regulatory inspections, including ensuring requirement documents are inspection-ready
• 2 years of experience with using regulated computer systems (e.g. Veeva, Trackwise, Master Control or similar)

 

What additional qualifications will make you a stronger candidate?

• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

 

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, vetera