Senior Director, Audits, Inspections, & QMS

Overview

Reporting to the SVP, Head of Quality Assurance & Quality Control, this is an enterprise leadership role and is responsible for providing strategic and operational leadership in the planning and execution of various elements across the Quality Management Systems (QMS).  To include all GxP audit programs across research, development, manufacturing, supply chain, regulatory, marketing and commercial, as well as direct oversight of the successful execution of all global, regulatory, GxP inspections.  This role is the owner and decision-maker administering Alnylam’s Quality Management Systems (QMS), inclusive of elements such as deviations, corrective/preventative actions, document control, training, etc.

This individual acts in a capacity such that they represent Alnylam to both external entities and senior internal stakeholders and requires the ability to influence and negotiate complex and time-sensitive interactions.  They are also responsible to ensure and oversee QMS/GxP governance forums and that monitoring activities are in place and are designed to demonstrate the health of Alnylam’s quality systems.

This position can be hybrid or onsite, with occasional on-site presence required in Cambride, MA.

Key Responsibilities

Audits & Inspections:

• Will maintain and oversee GxP Audit Programs and ensure audit planning is executed at a minimum annually (i.e., annual audit plans).
• Responsible to execute GxP audits in accordance with the approved plans, to include both internal (process) audits, external supplier/vendor audits, and external entities such as Investigator sites, IRBs, CROs, CMOs, partner audits, Safety Data Exchange Audits, etc.
• Responsible to execute oversight programs that ensure third parties (e.g., vendors, suppliers, etc.) are appropriately qualified and continued quality oversight is maintained (e.g., Quality Agreements, routine audits, etc.).
• This role will also define and execute global audit/inspection standards for external entities that audit or inspect Alnylam (e.g., development/marketing partners, regulatory inspections, etc.)
• Ensures timely submission of regulatory inspection responses and maintains oversight to ensure all regulatory inspection commitments are actioned and completed timely.
• Is the Quality representative and liaison for all Internal Audit (Finance) and Compliance & Ethics initiatives, interactions and shared work processes.

QMS:

• Responsible for developing, implementing, and maintaining a robust global GxP quality management system (QMS) applicable to research, development, manufacturing and commercial activities, aligned with GxP regulations and industry best practices.
• Provide GXP Quality Management System (QMS) process ownership and oversight for Audits & Self Inspections, Document Control & Retention, Training, Good Documentation Practices, Deviation, CAPA, Change Management, Regulatory Intelligence, Translations, etc. and responsible to oversee the execution of the QMS and state of compliance across the enterprise.
• Ensure process, monitoring and governance is in place to ensure compliance with applicable global regulatory requirements and guidelines
• Responsible to maintain the Global Quality Manual updated, and aligned with global regulatory expectations.
• Will ensure all local affiliate Quality Manuals are updated and aligned with the global expectations.
• Responsible to ensure governance forums and mechanisms are in place for all elements of the QMS (e.g., Quality Management Reviews, Quality Risk Management, Issue Escalation, Audits & Self Inspections, Supplier Oversight, etc.) and will provide oversight of those activities.
• Provides oversight of all Quality-owned processes and training, to include the Quality Policy and Quality Training Curricula.  And is responsible to ensure they are maintained in a state of compliance and meet current regulatory expectations.
• Leads the Global Document Control Team, owns the enterprise document management processes, and will ensure standards and the document hierarchy are maintained for SOPs, Work Instructions, Forms, Templates, etc.
• Responsible to manage the documentation and workflows within the electronic systems (Veeva) and support business stakeholders enterprise-wide with use of the system for both GxP and Non-GxP process.
• Partners with Alnylam’s Talent Acquisition Team and provides GxP oversight to ensure the execution of training activities allows for the documentation of individual training and qualifications, to support regulatory inspections and partner audits.
• Is the definitive decision-maker for Quality in terms of GxP training requirements and will work with business stakeholders to ensure global training programs meet regulatory expectations.
• Responsible for the Quality Regulatory Intelligence program activities and will oversee and ensure process and procedural updates based upon findings and decisions from updated requirements.
• Leads and facilitates the Change Control Review Board and maintains all associated documentation within the QMS.
• Partners across Quality and the business to ensures Quality Risk Management (QMR) process and governance are in place.
• Responsible to produce, monitor, and analyze metrics associated with Alnylam Quality Systems metrics and performance, and execute any necessary corrective actions.
• Acts as the designee for all Business Continuity/Disaster Recovery procedures and functions as the QA lead and Quality Management representative for all mock testing and incident response activities.

Qualifications

• 15-20+ years of experience in a regulated environment
• Bachelor of Arts, Bachelor of Science or equivalent work experience
• Extensive knowledge in a GxP area (GCP, GLP, GVP, GMP, GDP) and experience in more than one GxP area and device/combination product regulations desired.
• Experience with quality management processes (Document Management/Control, Learning Management System, Quality Event/CAPA, Audit & Inspection Management).
• Deep understanding of global regulations and guidelines pertaining to GxP activities (e.g., FDA, UK, EU, CAN, etc.)
• Demonstrated expertise in leading regulatory compliance initiatives and programs.
• Strategic mindset with execution-focus and passion for innovation.
• Effective oral and written communication skills.
• Excellent organizational and analytical skills and demonstrated ability to handle multiple projects at the same time and shift priorities when needed to meet a constantly changing environment.
• Ability to demonstrate clear alignment with Alnylam Core Values at a leadership level.
• Demonstrated success in hiring and staffing a growing organization as well as mentoring high potential individuals.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.