Quality Assurance GLP Lead

“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”

 -Bill Gates and Melinda French-Gates

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute. Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions. The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• Urgency: Execute with excellence to maximize impact.

• Collaboration: Establish empowered teams to drive our bottom line: lives saved.
• Innovation: Build on the known, uncover the new, achieve the unprecedented.
• Rigor: Drive the science, focus on the details, and execute with the highest quality.
• Courage: Dare to confront the world’s most significant global health challenges.

Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

The Gates MRI offers hybrid work arrangements, a 50% mix of on-site and work-from-home, and a competitive relocation package for those looking to move to the Cambridge, MA area. Remote employment is not offered for this role at this time.

THE POSITION

Reporting to the GCP Compliance Leader, The Quality Assurance GLP Lead will be responsible for managing GLP processes to ensure compliance with global laws, regulations and applicable guidelines. This role is responsible for fostering and promoting a GLP compliant environment with internal and external stakeholders and service providers, supporting a culture of quality, regulatory compliance and continuous inspection readiness.

 A summary of the responsibilities includes but is not limited to the following:

• Support & contribute to the execution of the QA Master Audit plan ensuring the conduct of GxP related audits. 
  • Includes service provider (e.g. clinical and non-clinical laboratories, CROs, etc.) audits, computer system validation audits, document audits and internal system/process audits. 
  • Oversight will span from audit identification, planning, conducting, reporting and closure
  • Ensuring implementation of corrective and preventative actions
• Support & track the management of GXP Audit deliverables & supports metrics reporting requirements.
• Supports audits through tracking audit process from scheduling through closure for QA audits.
• In collaboration with the GCP Compliance Leader, creates, implements, and maintains a fit-for-purpose Quality Management System (QMS). This will include on-going monitoring of QMS and implementation of continuous improvement.
• Support the QMS training program including all policies and procedures impacting Gates MRI employees. Manages the training and job qualifications documentation to ensure retrievability during a regulatory agency inspection.
• As needed, creates, reviews, and approves procedural documents (i.e., policies, standard operating procedures, etc.) ensuring compliance with regulations and guidance.
• Participates as a GLP QA member on project teams and serves as the GLP QA contact when questions or issues arise.
• Identifies and alerts the GCP Compliance Leader of internal and external GLP related quality issues
• Must have comprehensive knowledge of worldwide Regulations and Guidelines (non-clinical, GLP, Animal Welfare) that impact regulatory compliance. Expands knowledge of regulatory health authority regulations in regions where Gates MRI will conduct clinical trials.
• Working with other Gates MRI QA colleagues, implements a risk management program ensuring that GLP related risks are identified and remediated as appropriate ensuring on-going inspection readiness.
• Partners with external service providers to ensure their QMS is fit-for-purpose and/or meets the expectations of the Gates MRI commitment to Quality.
• Track and participates in internal investigations of potential issues at investigator sites, service providers, etc. to determine root cause and appropriate next steps.
• Participates in developing and implementing inspection preparation strategies and activities. Support GCP QA representative in regulatory health authority inspections interacting with regulatory health inspectors, as necessary.

QUALIFICATIONS

The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with a strong track record of hands-on experience in successful GLP Compliance with the following mix of personal and professional characteristics:

• 10+ years of experience in a laboratory- based setting with an additional 5+ years of relevant experience in quality assurance or related clinical and nonclinical laboratory quality assurance experience within biotech/pharma is required
• Minimum of bachelor’s degree required
• Experience in pharmaceutical development with a good understanding of the drug development process
• Significant Technical and scientific knowledge to manage quality operations related to QMS and quality assurance oversight for GLP activities
• Significant knowledge in the GLP regulations and guidelines (knowledge of GCP and GCLP is favorable)
• Attention to detail and accuracy in work
• Excellent verbal and written communication skills
• Strong interpersonal skills; ability to influence others in a highly matrixed organization
• Critical thinker with ability to synthesize information from multiple sources and apply problem solving
• Positive, self-starter, able to multi-task, with a hands-on, roll-up-the-sleeves style that gets things done and can thrive under pressure
• Strong ability to prioritize and operate with a sense of urgency
• Trustworthy with highest integrity, committed to ethics and scientific standards
• Team-oriented, collaborate style with the ability to build consensus amongst internal and external constituents
• Energetic, positive and flexible attitude
• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission

In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $200,000-$250,000 USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

If you require assistance due to a disability in the application or recruitment process, please submit a request here.

Inclusion Statement

We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.