Back to jobs
tags.new

Manager, PV Validation

Cambridge, MA, United States

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.

 

#LI-DNI

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf


Education

Select...
Select...
Select...
Select...
Select...

Recruitment Documentation

Accepted file types: pdf, doc, docx, txt, rtf

Please attach any additional recruitment documentation you would like considered in your application (i.e. cover letter, letter of reference or publications).

Select...
Select...
Select...
Select...
Select...
Select...

Please read the Privacy Policy to understand how Blueprint Medicines may collect and process personal data associated with your application.

Select...
Select...

We Invite You to Tell Us More About Yourself

At Blueprint Medicines, we foster a culture of equity, diversity and inclusion to empower the Blue Crew to bring their authentic selves to work. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all applicants without regard to any status protected under applicable law and we strive to employ qualified diverse talent. We encourage you to share information about yourself by answering the questions below, to help us comply with federal government reporting and recordkeeping requirements, evolve our ED&I initiatives, and measure the effectiveness of our efforts. Please review the Government Ethnicity and Race Definitions when answering those questions below.

Although all sections below require a response, you can always select "I don't wish to answer."  Your responses will be kept confidential and used only in a manner consistent with applicable law and will never be used against you. Thank you for sharing more about yourself and contributing to our affirmative action and diversity efforts. 


Voluntary Self-Identification of Protected Veteran Status

Blueprint Medicines is a government contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA). As such, we take affirmative action to employ and advance in employment protected veterans, including by reaching out to veterans' groups for qualified applicants and periodically reviewing our processes to ensure there are no unintended barriers. To help us measure the effectiveness of our outreach and recruitment efforts of veterans, we ask you to share if you are a veteran covered by VEVRAA.  Answering is completely voluntary, but we hope you will do so, and your response will be used and kept confidential consistent with VEVRAA, and will not be used against you in any way. Please review these Protected Veteran Descriptions and check the appropriate box further below as to whether you belong to any of these government-defined categories.


Voluntary Self-Identification of Disability

Form CC-305 OMB                                                                        Control Number 1250-0005
Page 1 of 1                                                                                                 Expires 04/30/2026                                                 

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Please check one of the boxes below:

Select...
Select...
Select...
Select...
Select...
Select...