Senior Manager, Quality Systems & Compliance

Blueprint Medicines; United States; On-site; USD 175,000 - 205,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Manager for Quality Systems & Compliance. This role involves overseeing GxP Training Programs and Document Control, ensuring compliance with industry standards. The ideal candidate will have extensive experience in document management and training, and a strong understanding of GxP principles. Join a team dedicated to transforming hope into reality for patients through innovative solutions.

Qualifications

• 6+ years of industry experience in training and document control.
• 5 years in a training and document control capacity.

Responsibilities

• Oversee management of GxP Training and Document Control Programs.
• Facilitate Quality Onboarding/Offboarding program for new GxP staff.
• Collect metrics on Policy and SOP and prepare reports.

Skills

Quality Assurance

Document Control

Training Program Management

Communication

Education

B.S. in life sciences

Tools

Veeva QualityDocs

Microsoft Office

Job description

Senior Manager, Quality Systems & Compliance

Senior Manager, Quality Systems & Compliance

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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 Blueprint’s 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, 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.
• Oversee Blueprint’s 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
• A team player, who listens effectively and invites response and discussion
• Excellent communication, collaboration, partnering, influencing and negotiation skills
• At home in a results-driven, 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?

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 [e-mail]. 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 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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