How will your role help us transform hope into reality?

Reporting to the Senior Director of Quality Systems & Compliance, the Director of Vendor and Audit Management will be primarily responsible for strategic and operational management of the GxP Audit program, supporting all clinical and commercial programs. You will have responsibility for leading a group ensuring that Blueprint and our vendors are in compliance with GxPs including the oversight of the GxP Master Vendor List and the implementation of effective tools for vendor evaluation, selection, qualification, and re-qualification. You will use a risk-based approach to manage internal and external audit resources while maintaining the program on budget. Working collaboratively across a wide range of partners within Quality and with GxP vendor business owners across the organization, you will maintain effective GxP Vendor Management and Audit Programs for the organization. The Director of Vendor and Audit Management is accountable for ensuring that outsourced third parties are audited and in compliance according to services provided and will work to continuously improve GxP processes and to support the state of GxP compliance at Blueprint Medicines.

 

What will you do?

• Manage a team of FTEs and contractors to oversee all vendor and audit programs for Blueprint GxP functions
• Utilize a deep understanding of GxP and regulatory requirements to execute on department and business objectives
• Create the vision, strategy, and goals for Vendor and Audit team
• Partner with the Quality leadership team to establish and lead Blueprint’s Global quality vendor management and internal and external audit programs
• Design, implement, and oversee the continuous improvement of the vendor management and internal audit program procedures and processes supporting the company’s global strategy
• Coordinate and manage all aspects of internal and vendor audit lifecycle: working with internal Quality and area management and consultants to schedule, plan, and track the reporting, responses, and closure of audits
• Implement internal and external audit plans based on established procedures and corporate and Quality compliance prioritizations
• Coordinate, schedule, and prioritize GxP audits for contract manufacturers, testing laboratories, clinical research organizations, external partners, etc.
• Develop excellent working relationships with the cross-functional quality team, GxP business partners, vendors, and other functions
• Monitor global audit trends and work with Quality area leads to inform of emerging areas of risk and regulations for incorporation into audit planning and execution
• Manage and oversee US and Global regulatory inspection logistics and lead preparations for and in support of preapproval and routine regulatory agency inspections
• Participate in short- and long-range planning of Vendor and Audit related activities planning, resourcing, and budgeting
• Identify compliance risks and escalate issues to appropriate levels of management
• Evaluate the needs for standard operating procedures and systems to comply with regulatory agencies
• Hire, train, and develop a highly functioning team of diverse and inclusive personnel
• Mentor staff and build processes that will drive innovation, teamwork, and efficiency within the organization
• Develop and report meaningful quality metrics for monthly, senior management, and Quality Management Review reporting
• Promote and advance a Quality Culture
• Identify opportunities to enhance continuous improvement and sustainable compliance for Vendors and Audits team through key performance indicators (KPIs)
• Work cross-functionally to proactively identify and lead quality risk assessments

 

What minimum qualifications do we require?

• Bachelor’s degree in chemistry, biology, engineering or related field or equivalent experience
• Minimum of 10+ years of relevant experience in Biotechnology/Pharmaceutical industry
• 5+ years' experience in the management of Vendor and Audit Programs GMP QA/QC/Compliance in all phases with a focus on commercialization
• Must be willing to travel domestically and internationally up to 25-35%

 

What additional qualifications will make you a stronger candidate?

• Demonstrated ability to lead both direct reports and in team environments
• Direct experience with Health Authority Inspections including Pre-Approval Inspections
• Excellent communication, writing, and presentation skills with both internal and external organizations
• Ability to assess complex issues and break down into viable solutions through risk management (FMEA, PHA, QRA, etc)
• Demonstrated ability to lead and organize team meetings
• Ability to foster effective relationships with vendors and colleagues
• Familiar with the infrastructure and operational characteristics of manufacturing and clinical development vendors providing GxP services
• Practical knowledge of global GxPs and ability to make sound judgement and risk-based decisions
• Demonstrated ability to be agile, flex resources, and pivot effectively in response to shifting business priorities
• Strong project management experience: ability to manage multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
• 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 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.

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