Blueprint Medicines is seeking an exceptional Quality leader to join and build its rapidly growing organization. Reporting to the Chief Legal Affairs & Compliance Officer, the VP of Quality will establish the vision and manage all aspects of Quality across the GCP, GLP, Quality Systems and GMP functions. The VP of Quality will be a resourceful and strategic thinker who will work internally across the Blueprint organization to provide the vision, results-oriented leadership and creativity required to build a world-class organization and establish a robust and efficient Quality System. As the Company’s head of Quality, the incumbent will work collaboratively with other functions to engage in proactive relationships with FDA and international regulatory authorities as appropriate and, when required, to present and defend strategies and approaches to facilitate the advancement of the Company’s goals and objectives.
- Develop and execute Quality strategy and goals commensurate with the overall plan for the Company, including supply chain and distribution activities. Manage the tracking and trending of department performance and quality indicators and make improvements and adjustments as required.
- Recruit, retain and develop first class talent responsible for providing Quality Assurance and Quality Control support to all Company operations. Build and sustain employee engagement by fostering a culture of rapid execution and a coaching environment in which individuals and teams can excel and continuously grow.
- Evaluate all Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of the Company’s near-term and long-term objectives.
- Lead efforts and collaborate with all internal and external partners to ensure readiness of all GLP, GCP and GMP activities for inspections associated with NDA filings.
- Lead or ensure appropriate Quality leadership of all partner and regulatory authority audits and inspections and corrective action programs in response to observations.
- Establish, improve and direct Quality programs, policies and procedures to ensure compliance with GxP standards, corporate policies, FDA and other regulatory guidelines.
- Establish and maintain a positive working relationship as a thought leader with FDA and other regulatory authorities. Represent the Company both internally and externally on any Quality and GxP compliance issues.
- Provide expertise and guidance in interpreting government regulations and guidelines as they apply to products and practices.
- Ensure that the organization is trained to the highest standards of Quality excellence and technical competency utilizing best in class processes and practices.
- Oversee the development of a risk assessment strategy reflective of the Company’s philosophy and approach to assessing and managing risk.
- Drive the use of strategies, technologies, resources and processes in support of Quality initiatives.
- Working with Finance and senior management, provide strategic input to the annual and long-range planning and budgetary process ensuring timely, effective use of resources.
It is anticipated that this position may require up to 20% travel time.
- Bachelor’s Degree in Quality Management or related science discipline. Advanced degree (MS, PhD, MBA) desired
- Minimum of 15-20 years of experience in pharmaceutical or biotechnology companies with 7-10 years in a senior Quality leadership role with increasing responsibility and track record of successful management and organizational skills
- Expert knowledge of GxP, FDA, EMA and other regional (e.g. PMDA) regulatory requirements
- Experience in multiple disciplines within Quality (e.g. auditing, GCP and GMP oversight, electronic systems management, laboratory management, PAI inspection readiness, commercialization and leadership)Demonstrated ability to multi-task, problem-solve and operate in a fast-paced environment
- Excellent verbal and written communication skills
- Sound judgment and commitment to ethical conduct
- Demonstrated practice of constructive engagement and possession of the confidence to challenge and be challenged to get the best strategies and solutions
- Knowledge of all business disciplines to ensure ability to develop strong collaborative relationships with all functional departments of the organization
- Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions
- Ability to work and communicate with all levels within the organization
- Strong organizational skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
- Ability to effectively and efficiently manage consultants, vendors and budgets
- Comfortable in a results-driven, highly accountable environment where you can make an impact
- Self-motivated, able to work independently and be reliable and responsive
- Commitment to proactively seeking, designing and implementing improvements and engaging with appropriate stakeholders to propose and implement solutions
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Strong professionalism and interpersonal skills
All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don’t think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.