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US

  • Serves as a dedicated strategic partner to assigned operational or functional business areas.
  • Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
  • Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.

Instructional Design GxP LMS Stakeholder Management Project Management

20 jobs similar to Senior Manager, GxP Strategic Training Partner , CMC (contract)

Jobs ranked by similarity.

US

  • Serve as a strategic document partner for assigned functional areas, aligning document development and records management with business, quality, and regulatory expectations
  • Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives
  • Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They have sites in North America, Europe, Australia, Latin America and the Middle East and are consistently recognized as one of the industry's top places to work.

US

  • Define and evolve the learning design strategy for Per Scholas’ curriculum portfolio.
  • Establish and maintain a robust quality system for all curriculum products.
  • Lead, coach, and develop a team of direct reports in product quality, EdTech, and accessibility.

Per Scholas aims to drive mobility and opportunity in the tech industry by training individuals and meeting employer needs through rigorous tech training. They have trained 30,000+ individuals and teamed up with dynamic employer partners, ranging from Fortune 500 companies to innovative startups, to forge inclusive tech talent pipelines.

Europe

  • Translate organisational capability needs into a clear, scalable learning strategy aligned with ABBYY’s business goals.
  • Design and develop high-quality learning content across multiple modalities (e-learning, virtual instructor-led, in-person, blended, toolkits, guides).
  • Conduct learning needs analyses to identify skill gaps, organisational requirements, and future capability needs.

ABBYY is a trusted partner for purpose-built AI and intelligent automation, and they solve highly complex problems for enterprise customers. They have over 600 employees across 15 countries and are guided by the values of respect, transparency, and simplicity.

US

  • Partner with GXP business leaders and translate objectives into comprehensive IT roadmaps.
  • Oversee selection, implementation, and validation of critical GXP systems.
  • Drive IT readiness for commercial launch including system scalability and disaster recovery.

Nuvalent is dedicated to creating selective medicines with the goal of addressing the needs of patients with cancer, leveraging deep expertise in chemistry. They are an early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

US 46w maternity

  • Design, develop, and maintain comprehensive training programs for new hire onboarding and process changes.
  • Deliver engaging training sessions to claims adjusters at all experience levels, including leadership.
  • Conduct training needs assessments using performance data analysis and surveys to identify skill gaps.

Openly is rebuilding insurance from the ground up, re-envisioning and enhancing every aspect of the customer experience. They are a rapidly growing team of exceptional, curious, empathetic people with a wide range of skill sets.

$100,000–$150,000/yr
US

  • Owns the strategy, execution, and evolution of how learning happens across the organization.
  • Leads a fully remote national training team while remaining deeply embedded in the field.
  • Actively facilitates training, co-creates content with subject matter experts, pilot new programs.

They are the fastest growing garage door platform in the industry. They consistently develop leaders, technicians, sales professionals, and support teams across dozens of brands which directly drives performance, retention, and culture.

$150,034–$224,250/yr
US

  • Execute the strategic FMA training plan supporting the therapeutic area Business Unit and new product launch initiatives.
  • Develop and refine the GMA new hire FMA learning curriculum for their therapeutic area (i.e., Nephrology/Immunology).
  • Lead virtual classrooms, competency assessments & certifications (live and virtual) and serve as a key presenter and co-author of the Peak Performers series.

Otsuka is a global healthcare company committed to developing and commercializing innovative products in neuroscience, nephrology, and digital medicine. The company employs 34,400 people worldwide, including 2,200 in the U.S., and is dedicated to defying limitations for patients and earning recognition as a Great Place to Work.

US Canada India Europe

  • Own the overall enablement content architecture, defining how learning content is structured, modularized, governed, and scaled across programs.
  • Partner with SMEs, Product, and Operations leaders to understand enablement needs and translate business and product requirements into effective learning solutions.
  • Manage and develop a distributed instructional design team across North America and India, providing coaching, feedback, and performance management.

Juniper Square's mission is to unlock the full potential of private markets by digitizing these markets, bringing efficiency, transparency, and access. They value contributing as a member of a values-driven organization, with employees working remotely or from physical offices in multiple locations.

US Unlimited PTO 12w paternity

  • Design and develop customer-facing training content.
  • Apply instructional design best practices to create learning experiences.
  • Work closely with multiple teams to gather content and align training.

SmarterDx builds clinical AI that transforms how hospitals translate care into payment. Founded by physicians in 2020, their platform connects clinical context with revenue intelligence, helping health systems recover millions in missed revenue, improve quality scores, and appeal every denial.

US

  • Develop and lead the enterprise compliance strategy aligned with institutional growth plans and regulatory expectations.
  • Oversee preparation and submission of substantive change applications and institutional reporting requirements.
  • Establish enterprise compliance training framework for corporate and campus leaders.

Cotulla Education transforms lives through hands-on, career-focused education. They empower students to achieve their professional dreams in high-demand fields. With experienced faculty providing personalized support, their graduates emerge as future leaders ready to make a significant impact.

India

  • Responsible for analyzing, designing, developing, and delivering high-quality learning solutions that align with organizational goals and objectives.
  • Collaborate with subject matter experts, and other members of the training and enablement team, to create engaging and effective training courses using instructional design methodologies and emerging technologies.
  • Design and develop innovative and interactive learning experiences using instructional design principles, adult learning theory, and best practices.

Kinaxis is a global leader in end-to-end supply chain management which enables supply chain excellence for all industries. They have over 2000 employees around the world, and support 40,000+ users in over 100 countries, building a high-trust and high-performance culture to be Great Place to Work Certified.

US

  • Craft and implement an onboarding strategy for new and existing employees.
  • Collaborate with various departments to identify learning opportunities.
  • Evaluate curriculum effectiveness through data analysis and feedback.

Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. They identify the top-fitting candidates, and this shortlist is then shared directly with the hiring company.

US

  • Develop and execute comprehensive training strategies and learning roadmaps aligned to organizational goals.
  • Lead the design and development of instructional materials grounded in adult learning principles.
  • Develop and execute OCM strategies appropriate to each client’s environment.

BerryDunn is a professional services firm helping businesses, nonprofits, and government agencies throughout the US solve their greatest challenges. They are client-centred and people-first with a mission to empower the meaningful growth of their people, clients, and communities.

$60,000–$90,000/yr
US

  • Revise, expand, and optimize onboarding materials and workflows to create a standardized, role-specific, and site-relevant onboarding program.
  • Deliver hands-on, in-person onboarding and provide ongoing virtual support during the initial integration period and beyond, ensuring continuous guidance and reinforcement of learning.
  • Collaborate with Subject Matter Experts (SMEs) and other stakeholders to ensure educational content reflects current regulatory standards, organizational priorities, and best practices in clinical operations.

Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. They have hundreds of research locations, mobile clinics, and clinicians across the globe to ensure every person has the opportunity to understand their health, access the care they need, and contribute to medical breakthroughs.

US

  • Set submission strategy and operational timelines.
  • Build, evolve, and manage the Regulatory Operations infrastructure.
  • Establish and oversee training on RA procedures and submission standards.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.

US

  • Own the end-to-end promotional medical education function.
  • Establish an integrated promotional education roadmap aligned to company objectives and customer needs.
  • Deliver high-quality educational experiences through live, virtual, and hybrid formats.

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. They are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of their investigational COMP360 synthetic psilocybin treatment.

US

  • Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
  • Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
  • Develop and implement inspection readiness plans and procedures for Health Authority inspections.

Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.

$100,000–$115,000/yr
US

  • Lead and coach a distributed team of virtual teachers to achieve high-quality, standards‑aligned instruction.
  • Drive instructional program quality and consistency across assigned states or regions, ensuring compliance, student success, and district satisfaction.
  • Own teacher training and enablement through LMS leadership—designing engaging, data-informed professional learning rooted in adult learning theory.

Edmentum is a dynamic educator and student-focused company dedicated to tech-enabled learning solutions. They aim to ensure all students have access to flexible learning environments and educators have the tools they need to support their students. They are a Remote First organization.

$95,000–$105,000/yr
US Australia UK 6w PTO

  • Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS using a risk-based approach.
  • Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management.
  • Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule, including initial qualification, periodic requalification, performance monitoring.

Cogstate is advancing the science of brain health - making it faster, easier, and more accurate to assess cognition across clinical trials, healthcare settings, and everyday life. Our global team of experts spans psychology, data science, operations, and technology.

$320,000–$350,000/yr
US

  • Define and execute global CMC regulatory strategies for investigational and marketing applications.
  • Lead preparation, review, and approval of CMC sections for regulatory submissions.
  • Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.