Manager, PV Validation

Title:  Manager, PV Validation

Location: Cambridge, MA

Requisition Number: 25-600

 

How will your role help us transform hope into reality?

Job Duties: Manage the day-to-day operational activities of the PV Systems, including safety databases, and ensure that performed tasks comply with Drug Safety and Pharmacovigilance SOPs and policies, best industry standards, and applicable regulations. 

 

What will you do?

Duties include:

• Work closely with drug safety / pharmacovigilance (DSPV) business users to understand system requirements and recommend solutions;
• Monitor compliance with regulations, PV agreements and internal SOPs;
• Analyze and develop UAT scripts and support during UAT executions;
• Collaborate with Quality Assurance Department (CSV) and IT to oversee and document the CAPAs and other quality items to ensure compliance with company and regulatory standards;
• Participate in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices;
• Collaborate with Safety database vendor for change controls management, incident management, issues resolutions, and on-going projects;
• Act as Project Manager for systems projects within Drug Safety and Pharmacovigilance (DSPV); and
• Identify and define solutions to troubleshoot the Safety database.

May telecommute up to 2 days per week.

 

What minimum qualifications do we require?

Position Requirements: Master’s degree in computer science, Industrial Engineering, or a closely related field (or foreign equivalent degree), plus 2 years of experience in database systems QA.

 

Experience, which may be gained concurrently, must include:

• 1 year of experience in SDLC, managing system implementation and validation projects under change control within the pharmaceutical or biotechnology industries.
• 1 year of authoring and reviewing validation deliverables, developing User Acceptance Testing (UAT) scripts, coordinating, and supporting UAT executions.
• 1 year of experience in incident management, conducting root cause analysis, troubleshooting to address end user queries and define resolutions.
• 1 year of experience in conducting risk assessments for the system upgrades and maintaining the validated state of systems.
• 1 year of experience in working with GxP requirements and FDA 21 CFR Part11, EU Annex11 regulations, understanding and monitoring compliance with applicable industry regulations and standards, and company internal SOPs/Policies.  
• 1 year of experience in collaborating with cross functional teams and vendors for overseeing and documenting Quality events such as incidents, CAPAs and deviations, driving the implementation of remediation.
• 1 year of experience in supporting audits and inspection, and vendor management.
• 2 years of experience with SQL programming knowledge or any additional data analysis and reporting tools.
• Strong communication skills.
• Strong problem-solving skills with knowledge of process control, and continuous improvement activities.
• Strong project management skills and ability to develop and manage timelines for multiple ongoing projects.

 

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, 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 E-Verify Participation Poster, the Right to Work Poster, and/or the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

 

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 is part of Blueprint Medicines’ employee referral program and is eligible for an employee referral incentive bonus.

 

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