Manager PV Validation
Manager PV Validation
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Job Description
Title: Manager PV Validation
Location: Cambridge MA
Requisition Number: 25600
How will your role help us transform hope into reality
Job Duties: Manage the daytoday 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 ongoing 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: Masters 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 problemsolving skills with knowledge of process control and continuous improvement activities.
- Strong project management skills and ability to develop and manage timelines formultiple 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 EVerify 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
For more information please see ourEEOAA Policy Statement the EVerify Participation Poster the Right to Work Poster and/or theEEO Know Your Rights Poster as well as ourPay Transparency Statement.
Blueprint Medicines is a global fully integrated biopharmaceutical company that invents lifechanging 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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Required Experience:
Manager
Employment Type
Full Time
