Associate Director, Document Management & Training QMS

Responsibilities:
- Oversee the strategy, development, and management of GxP Document and Training programs and related documentation (Veeva/ComplianceWire), ensuring compliance (GxP), and meeting regulations, quality standards, and business goals
- Develop and implement documentation/training strategic plans; manage departmental goals and lead cross-functional teams
- Serve as SME for electronic learning and document management systems (user support, system improvements, and data management)
- Lead upgrades and changes to Veeva and ComplianceWire in partnership with the vendor and internal stakeholders
- Oversee periodic reviews of controlled documents (e.g., Policy, SOPs, Work Instructions) with GxP business areas
- Ensure compliance with legal/regulatory standards for document storage and retention
- Oversee company training program in partnership with Compliance and non-GxP areas; improve onboarding training for new employees
- Define job-specific training requirements in role curriculum/matrix and gather training records for audits/inspections
- Create and manage job-specific curriculum/training matrices for GxP functional areas
- Lead Document and Training Board meetings and Quality Management Review activities (document revisions, reviews, training assignments, annual curriculum reviews, and monthly metrics)
- Lead/support inspection readiness activities and regulatory inspections (on-site and remote)
- Manage and coach direct/indirect reports, plus consultants/contractors

Qualifications:
- Bachelor’s degree in science (or related field) with 8–10+ years of GxP Quality experience in life sciences (or equivalent)
- 5+ years hands-on experience hosting internal/external audits and regulatory inspections
- Demonstrated experience managing pharmaceutical quality systems (Management Review, Document Management, Training, Deviation/Investigation, CAPA, Quality Metrics)
- Experience with Veeva and ComplianceWire (or other quality/training management systems)
- Excellent communication, time management, and presentation skills; strong leadership and project management
- Ability to project manage and lead cross-functional teams in a fast-paced environment

Benefits (as stated): 401(k) with generous employer match, 12 weeks paid parental leave, up to 12 weeks living organ/bone marrow leave, equity incentive plans, health plans (medical/prescription/dental/vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, at least 11 paid holidays

Hybrid: Hybrid role based in Waltham, MA; requires on-site presence 2–3 days/week.