Manager, Training & Risk Management

How will your role help us transform hope into reality?

This is an excellent opportunity to be responsible for the oversight and execution of GxP Training and Risk Management Programs. Primary functions include: training curricula and assignment processes, onboarding, administration and coordination of Risk Register. Additionally, this staff will act as business process administrator for GxP Policy and Standard Operating Procedural (SOP) Document Control and Training and coordinator in Blueprint’s electronic Document Management System (EDMS) and electronic Learning Management System (LMS).

 

What will you do?

• Act as a lead in the operations, on-going design improvements, partnering, scheduling, and delivery of the GxP Training program to staff inclusive of training curricula, staff assignments, tracking and communications.
• Facilitate the Quality Onboarding/Offboarding program of new GxP staff.
• Work cross-functionally with Functional Area Leads to develop and implement effective, group-specific training curricula.
• Manages process eLMS improvements
• Acts as the Business Administrator for eDMS/eLMS to support GxP departments in processing documents and administer training
• Collects metrics on Training systems and prepares metrics reports
• Supports the Risk Management Program by being the point of contact for the intake and triage of risks, coordination of risk governance meetings and maintenance of the risk register
• Provide back-up support for formatting, QC review, and Quality Checks on procedural (SOPs, POLs, WIs, GDs etc.) controlled documents
• Provides back-up support in the intake of product complaints
• Promotes and advances a Quality Culture through partnership, communication, and transparency
• Support regulatory agencies Governance and Procedure and Training inspection requests
• Perform other responsibilities as assigned.

 

What minimum qualifications do we require?

• 3+ years of relevant QA and GxP Experience
• Bachelor degree or relevant experience
• Experience in Veeva QualitySuite including QualityDocs, Training and eQMS required
• Training Program Management, Procedural and GxP Document Control experience

 

What additional qualifications will make you a stronger candidate? 

• Extensive knowledge of GxP and Quality principles, practices, and standards
• Strong knowledge of global regulations (EU, US)
• Excellent communication, collaboration, partnering, influencing and negotiation skills is a must.
• Demonstrated advanced Microsoft Office suite knowledge and use skill sets
• Ability to effectively prioritize and manage multiple projects and tasks.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.
• Ability to effectively prioritize and manage multiple projects and tasks.
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
• At home in a results-driven, highly accountable environment where you can make a clear impact.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

 

Why Blueprint?

At Blueprint Medicines, patients are our purpose. Their needs ignite our innovation, fuel our urgency and inspire us to go further - faster. We bet on bold people who want to grow, push boundaries and lead meaningful change. Here, you’ll do the most impactful work of your career - because our commitment to changing lives isn’t just what we do, it’s who we are.

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

 

Compensation and Benefits 

The base salary hiring range for this position will be $115,000 -- $160,000*.  Actual base salary offered for this position will be based on a number of job-related factors, including, but not limited to: experience (including skills and competencies), education, training and internal equity.

This position is also eligible for the following:

• Participation in annual bonus program based on Company and individual performance, subject to the standard terms and conditions of the program
• Inclusive total rewards offerings focused on employee choice and professional and personal well-being. These include: medical, dental and vision benefits; Modern Health mental health and coaching benefits; medical and dependent care FSAs; generous paid time off (typically includes one-week well-being shutdowns at mid-year and year-end); subsidized commuting or parking benefits; 401(k) with match;  generous paid medical, parental and family leave programs; disability benefits and more.

*Based on reasonable estimate for this job at the time of posting; ranges are reviewed periodically and subject to change.

To apply, just scroll down and click on the “Apply Now” link. 

 

Equal Employment Opportunity

At Blueprint Medicines, we foster an environment of fair treatment and full participation for all of our employees as we navigate complex challenges in pursuing our mission to improve the lives of patients. We celebrate our unique differences and varied career and life experiences so that we can sustain our diverse culture and ensure everyone feels accepted. We are committed to non-discrimination, equal employment opportunity, as well as an inclusive recruitment process. We consider all qualified applicants based on merit and without regard to race, color, sex, gender identity, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable federal or state law.  

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. We are also an E-Verify Employer. For more information, please see our EEO Policy Statement, the E-Verify Participation Poster, the Right to Work Poster, and/or the EEO Know Your Rights Poster.

Blueprint Medicines, a Sanofi company, is a global biopharmaceutical company that invents life-changing medicines. We seek to improve and extend patients' lives by solving important medical problems, with a focus on 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 track record of success with two approved medicines, including AYVAKIT/AYVAKYT (avapritinib) which we are bringing to patients with SM in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we 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 and solid tumors. For more information, visit www.BlueprintMedicines.com and follow us on X (formerly Twitter; @BlueprintMeds) and LinkedIn.

 

#LI-DNI