Senior Manager, Standards, Process & Training

Alnylam Pharmaceuticals • Cambridge, MA

1d

About The Position

Reporting to the Associate Director of Standards, Process & Training – Clinical Development, the Sr Manager, GCP Process Management serves as a process excellence Subject Matter Expert (SME) on process improvement, management and effectiveness. The role is responsible for the life-cycle management of controlled procedural documents (e.g., Standard Operating Procedures, Work Instructions) and managed documents (e.g., tools, guidelines) related to GCP and clinical trials. The role is responsible for facilitating process development, review, approval, training and effectiveness checks and ensuring alignment with GCPs, regulations and laws. This role partners with Expertise Areas (EAs) across Development to drive the consistent application of standards and promotes a culture of sustainable compliance, continuous improvement, and inspection readiness. In addition, the role leads and participates in initiatives aimed at innovation, quality, continuous process improvement and efficiency that align with organizational strategies and goals.

Requirements

• University Degree in Science and/or a relevant discipline.
• Minimum 8+ years experience with a biopharmaceutical company and/or CRO and a track record of success in global clinical development or related disciplines including:
• Extensive experience in activities related to process improvement; SOP development and review, role-based curriculum management
• Proven ability to design/evolve and implement GCP related processes (e.g., SOPs, Work Instructions) in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic business model
• Experience in global clinical study/site management
• Understanding of the processes required to operationally execute clinical trials to a high standard of excellence
• Strong knowledge of GCP, global regulatory and compliance requirements for clinical trials.
• Knowledge of industry trends and best practices for process quality, efficiency, compliance, and effectiveness.
• Knowledge of managing within EDMS and LMS systems
• Demonstrated ability to coach, motivate and influence high performing colleagues across areas to deliver
• Ability to execute work independently and with minimal supervision
• Ability to respond to change with agility, resilience, innovation, and optimism, seeking solutions based on creative problem solving, lessons learned and well-reasoned risk taking
• Detail oriented & possess technical expertise
• Strong communication (written, verbal, presentation) and analytical skills
• Able to accommodate limited travel (may include international travel) according to business need (~10%)
• Alignment with Alnylam's Core Values: Fiercely Innovative, Open Culture, Purposeful Urgency, Passion for Excellence, Commitment to People

Nice To Haves

• Knowledge of Process Mapping strategies and tools strongly preferred

Responsibilities

• Leads the development, periodic review, and continuous improvement of GCP and clinical trial-related processes across Clinical Development.
• Owns the clinical process development portfolio, including prioritization, sequencing, and resourcing of initiatives in alignment with business strategy and risk.
• Establishes and evolves process governance frameworks, standards, and best practices to ensure consistency and scalability.
• Drives or consults on the identification and implementation of process related change management needs
• Drives maintenance of the Process Portal to ensure easy access to the end-to-end clinical trial-related process families
• Partners with Process SMEs and Operational Effectiveness to implement process revisions identified in effectiveness checks
• Partners with EAs to proactively identify learning gaps; seek out, identify, and drive process improvements with a focus on standardization
• Drives process inspection readiness
• Consulting on CAPAs/Quality Events related to clinical trial processes
• Represent Process Excellence by leading and/or participating in working groups and initiatives that drive the healthy conduct of clinical trials and helps the business scales for the future

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior