Associate Director - Chemical Platform Learning Architect With a very nice relocation package those people willing to work in, reside in/near Huntsville Alabama or Houston TX may be considered 1stAre you the right candidate for this opportunity Make sure to read the full description below. I will get you an interview if you are fully qualified Would you please clear my phone # on your voice screening? Feel free to call my land line, 86 until 8 PM EST 7 days a week as you can take notes & "after" you email a word docx resume to me- Ideal Candidate The ideal candidate would possess…Start-Up Mentality: Ability to operate with speed, adaptability, and ownership in environments that are still forming. Learning & Development Experience: Deep understanding of how adults learn in complex, regulated environments to drive qualification strategy and execution. Pharma / Manufacturing Background: Credible knowledge of regulated manufacturing and quality environments. GMP essential. Formal Leadership Experience: Proven ability to lead people, influence stakeholders, and deliver outcomes through others. Screening Questions Program Design: If you had to build a role-based qualification program from zero for a GMP manufacturing area, what are the main steps you’d follow from job task analysis through qualification sign-off? Controls & Governance: How do you define and control qualification requirements (e.g., curricula, prerequisites, OJT, assessors, requalification) so it holds up in audits/inspections and stays current with changes (SOP/process/equipment)?Assessment & Effectiveness: What methods do you use to verify competency (not just completion)—and what metrics would you track to prove the qualification program is working (e.g., deviations, right-first-time, time-to-qualify, retraining triggers)?Resilience & Operating Under Pressure: Can you describe a time you had to keep training and/or qualification on track during a major disruption (e.g., inspection readiness crunch, deviation spike, system outage, staffing gaps)? What did you prioritize Our company is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX and Huntsville, AL. These facilities are one of the company's largest investments in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the Houston or Alabama Plant team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Job Position Overview:
The Global Manufacturing and Quality Learning & Development (GMQLD) team is dedicated to delivering learning solutions that empower the company's Manufacturing and Quality organizations to achieve our mission: making medicine with safety first and quality always. The Learning Architect (LA) is a platform-specific learning professional responsible for designing and maintaining training that serves an entire manufacturing platform. Located at platform sites or Indianapolis, the LA addresses 90% platform-level and 10% site-level content needs, designing within COE standards and governance frameworks.
Responsibilities:
The LA is accountable for platform-specific curriculum design, development, and maintenance within the GMQLD operating model. The LA partners with site SMEs, Platform Leads, and the COE to ensure training content is current, compliant, and aligned to manufacturing process needs.
Platform Curriculum Design & Development:
- Design and develop platform-specific training content within COE governance frameworks and global standards.
- Address 90% platform-level content and 10% site-specific needs, as assigned by the Platform Lead.
- Partner with site Subject Matter Experts (SMEs) on curriculum development, ensuring content reflects current manufacturing processes.
- Apply process-based curricula principles — organize content by manufacturing process with task-level qualification.
- Ensure curriculum aligns to the three-layer content model (Global / Platform / Site).Content Governance & Quality:
- Design content within COE standards, governance frameworks, and compliance requirements.
- Feed content gaps and site needs up to Platform Lead and COE for resolution.
- Pull global content from COE as foundation for platform-specific curriculum.
- Support learning equivalency, exception and substitution decisions in alignment with the Quality system.
- Collaboration & Stakeholder Partnership:
- Partner with Platform Lead (M2/P4) on L&D strategy and business priorities across platform site
- Interface with COE for standards, governance, and cross-platform alignment.
- Collaborate with LEPs to understand site-specific execution needs and inform curriculum updates.
- Represent the platform in cross-functional forums, audits, and governance reviews.
- Continuous Improvement:
- Support Time to Qualification optimization initiatives by identifying training burden, content redundancy, and qualification bottlenecks.
- Contribute to OJT standardization across platform sites.
- Use data to identify improvement opportunities in curriculum effectiveness and qualification outcomes.
Basic Qualifications:- Bachelor's degree 5+ years' experience in a regulated environment.
- Area or functional specific expertise in Learning & Development, instructional design, and Manufacturing/Quality operations.
- Experience with curriculum design, learning management systems, and GMP training requirements.
- Strong understanding of GxP and Good Manufacturing Practices (GMP), regulatory requirements, and compliance training.
- Additional Skills/ Preferences:
- Deep knowledge of platform-specific manufacturing processes (e.g., PFS, Cartridge, DAP/EM, Chemical, Biologics).Experience with process-based or competency-based curriculum architecture.
- Ability to work across multiple sites and time zones.
- Strong collaboration skills with cross-functional teams (Quality, Operations, Engineering).Experience with digital learning tools, DOJT, or OJT standardization. xhqgsiq Familiarity with Workday, Success
- Factors, or equivalent HR/learning systems.
- Travel Percentage (%): 10%Skills and Certifications [note: bold skills and certification are required]GMP experience
- Start-up mentality
- Learning & Development Experience
Base Salary: USD $127,500 to $187,000 perhaps more
Relocation Assistance Available - Yes7+ to 10 years experience
Seniority Level: Mid-Senior
Management Experience Required - YesMinimum Education - Bachelor's Degree Willingness to Travel - Occasionally
