Heidi Steklis

About Heidi Steklis

I am a collaborative, detail‑oriented QA/QC leader with 25+ years of experience driving quality excellence, regulatory compliance, and operational efficiency across large and small molecule environments. I am known for simplifying complex processes, strengthening global Quality Systems, and implementing scalable solutions that enhance alignment, training, and execution across teams. I am skilled at optimizing Clinical Operations processes, managing SOPs and QMS platforms, leading audits and inspection readiness, and partnering with leadership to advance organizational goals. I am known for being a trusted SME and cross‑functional collaborator who builds strong quality cultures, elevates performance, and ensures consistent compliance in fast‑paced, highly regulated settings.SCOPE OF PRACTICE- Quality Assurance & Quality Control Leadership- Clinical Operations Process Optimization- Global Regulatory Compliance & Inspection Readiness- GxP Quality Systems Management- Document Control & Training Program Oversight- QMS Ownership (EDMS, LMS)- Audit Management (Internal, External, Regulatory)- Change Control, CAPA, Deviation & Investigation Management- Cross‑Functional Collaboration (QA, IT, SMEs, Operations)- System Implementation & Validation (CTMS, eTMF, EDMS, eClinical)- Continuous Improvement & Quality Program Development- Multi‑site Quality Operations LeadershipSOFT SKILLS- Clear and concise communicator- Collaborative and influential partner across teams- Strong leadership presence; able to inspire and guide others- Detail‑oriented with strong organizational discipline- Skilled at simplifying complex processes and requirements- Effective at managing competing priorities and deadlines- Adaptable, proactive, and solutions‑focused- Skilled at stakeholder alignment and expectation management- Able to foster a culture of quality, consistency, and improvementAREAS OF EXPERTISE- Quality Systems Management - Clinical Operations Quality Support- SOP Management, Document Control, and Controlled Document Changes- Training Program Development, Curriculum Management, SME Networks- Audit Leadership, Inspection Preparation, and Regulatory Response- CAPA, Change Control, Deviations, Batch Release, Stability Oversight- System Implementation, Validation, and User Training- Metrics, KPIs, and Executive Reporting- Multi‑site Quality Oversight and Compliance Governance- Cross‑functional Quality Collaboration (QA, QC, IT, Manufacturing, Labs)HOBBIES-Camping, Hiking, Standup Paddleboarding, Pickleball, Scuba.

Experience

1. Manager, Training and Enablement

   Agios Pharmaceuticals

   Jun 2025 — Present · Boston, MA, US

   Oversee SOP ownership, development, and management to ensure GCP, regulatory, organizational, and industry compliance. • Serve as primary QA contact forocess-related events (QE & CAPA) communicating updates to the department.• Strategic partner to Clinical Operations leadership, driving engagement and performance, and liaising with other departments to integrate processes, tools, and systems.• Established Clinical Operations subject matter expert network and implemented framework for role definition & development.• Developed and managed a training improvement program impacting ~50 cross-functional users, delivering department-wide training and new SOP creation.

Education

• Charter Oak State College

  Bachelor of Science - BS, Biology and Management

• Chabot College

  Associate of Arts - AA, General Education

Skills

• Quality Assurance
• Biotechnology
• Capa
• Nutritional Counseling
• Biopharmaceuticals
• Partner Management
• Cgmp
• Japanese Business Culture
• Quality System
• Quality Systems
• Filtration
• Change Control
• Regulatory Requirements
• Fermentation
• Fermentation Technology
• Pharmaceutical Industry
• Sop
• Fda
• Purification
• Bioprocessing
• Investigation
• Risk Management
• Gmp
• U.s. Food and Drug Administration (Fda)
• Validation
• Computer System Validation
• 21 Cfr Part 11
• Sdlc