Senior Manager, Quality Systems & Compliance
Senior Manager, Quality Systems & Compliance
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Job Description
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 Program Procedural Document Administration and Document Control. Primary functions include management oversight and lifecycle administration of Blueprint procedural document control training curricula and assignment processes metrics reporting and document control including document control room. Additionally you will act as business process administrator for GxP Policy and Standard Operating Procedural (SOP) Document Control and Training and coordinator in Blueprints electronic Document Management System (EDMS) and electronic Learning Management System (LMS).
What will you do
- Oversee the management of GxP Training Procedural and GxP Document Control Programs
- Act as a lead in the operations ongoing 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 crossfunctionally with Functional Area Leads to develop and implement effective groupspecific training curricula.
- Oversee Blueprints Procedural Document Control p management QC reviews review and approval assignment release tracking and reporting.
- Oversees the formatting QC review and Quality Checks on procedural (SOPs POLs WIs GDs etc.) controlled documents
- Manages process and eDMS and eLMS improvements
- Acts as the Business Administrator for eDMS/eLMS to support GxP departments in processing documents and administer training
- Collects metrics on Policy and SOP and Training systems and prepares metrics reports
- Promotes and advances a Quality Culture through partnership communication and transparency
- Support regulatory agencies Governance and Procedure and Training inspection requests
What minimum qualifications do we require
- B.S. in life sciences chemistry or a relevant field with 6 years of industry experience with at least 5 years in a training and document control capacity
What additional qualifications will make you a stronger candidate
- Extensive knowledge and experience in Veeva QualityDocs and Training
- Training Program Management Procedural and GxP Document Control experience
- Experience in Policy and SOP Lifecycle management and user support
- Extensive knowledge of GxP and Quality principles practices and standards
- Strong knowledge of global regulations (EU US)
- Demonstrated advanced Microsoft Office suite knowledge and use skill sets
- Ability to effectively prioritize and manage multiple projects and tasks
- People management experience preferred
- A team player who listens effectively and invites response and discussion
- Excellent communication collaboration partnering influencing and negotiation skills
- At home in a resultsdriven highly accountable environment where you can make a clear impact
- 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
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 nondiscrimination 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. We are also an EVerify Employer. For more information please see our EEO Policy Statement the EVerify Participation Poster the Right to Work Poster and/or the EEO Know Your Rights Poster.
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.
#LIHybrid #LIAQ1
Required Experience:
Senior Manager
Employment Type
Full Time
